Category: Pharmacy

Purpose

V-blenders are used mostly in pharmaceutical companies. The blender is the key played in the mixing process of various components used in the production of drugs. The paper aims to present a standard procedure to be used in cleaning the V-blender. This will ensure that the components produced meet quality standards. There will be defective products from contamination from other components from the V-blender (Tekchandaney 2).

Scope

This information applies to all individuals who may use the V-blender at some point in the production process. This aids in the cleaning of the blender. Care should also be taken to ensure the surrounding and components to be mixed are not contaminated.

Definitions of words used in the paper

• IPA means Isopropyl alcohol
• Approved detergents  are detergents that have been recommended for cleaning by the facility and specified for the V- blender
• Harmful chemicals  this are substances that when exposed or released to the environment may alter the natural state the environment that might result to destruction of the flora and fauna and harm the human population

List of equipment used in cleaning the V-blender

1. Gallons of well-labeled plastic buckets
2. Disposable wipes
3. Purified wipes for cleaning to ensure sterility of the gasket
4. Brush and long handle mobs
5. Specific vacuum cleaner for the gasket
6. Water hoses clearly labeled for the purified water, cold and hot purified water
7. Specialized flash light for observation after cleaning

Cleaning solutions

1. Approved detergents for the purpose at hand
2. 70% IPA used to sanitize the V-blender
3. Distilled water

Responsible persons

There should be at least two technicians assigned to clean the V-blender. They should be well trained and approved by the relevant bodies in the pharmaceutical industry. This ensures there is professionalism and minimizes the likelihood of defective drugs.

Procedure

1. Tag the equipment with a cleaning label, indicating not in used.
2. The technicians ensure they have the required protective clothing before the start of the process
3. Disconnect the power cable and remove the lid
4. Remove any visible materials from the blender (gasket) and place them in disposable sterile bags. This ensures that they are not disposed dangerously. They can be harmful chemicals to the people and the environment.
5. Cleaning the gasket starts by using a long handle mob
6. Spray the gasket with hot purified water and close the lid. Switch on the power and run the blender on a low knob to mix the detergents and cleaning agents.
7. Discard the contents using the discharge valve.
8. Use the brush to remove any residual remaining in the gasket
9. Fill the gasket with cold water and run the blender again on a low knob
10. Discard the contents using the lower valve.
11. Use the flashlight to check if there is any residual remaining in the gasket. If there is any residual, the procedure is repeated from step 5.
12. After ensuring that there is no residual, fill the gasket with 10 USG of IPA using the plastic gallons. Close the gasket and run the blender on a low knob again to ensure the solution covers the entire surface.
13. Drain the solution
14. Wipe the exterior part that may have been exposed to the cleaning agents or solutions using disposable wipes.
15. Then use the purity wipes to wipe the inside of the gasket. This is to remove the IPA solution.
16. Allow a 30 minutes window before closing the lid of the blender.
17. Collect the disposable wipes and sterile bags drop them in the allocated garbage bins.
18. Clean the brush, gallons, and mobs, and then wipe the floor dry from any liquid or detergent.
19. Ensure that the cleaning equipment and remaining solutions and detergents are returned to their correct storage area. This will avoid any mixing and ease of access by other users.
20. Inspect the V-blender from any defaults. This may be from rust leaking breakages of spillage. A standard form is t filled, signed, and handed to the housekeeping manager. This is critical for referencing, inspection, and audit in case any issue arises.
21. Remove the protective clothing and hand over to housekeeping for cleaning.

References to Standards, Manuals or relates Standard Operating Procedure

The World Health Organization (WHO) provides some cleaning validation for equipments. This is to ensure that there is no contamination of products. WHO also stresses the need of using soluble detergents so as they do not leave residual on the cleaned surfaces. There is also need for a standard cleaning procedure for equipments. The process is documented to show evidence that there was cleaning on a certain date. An organization can choose to have routine cleaning exercises on major cleaning conducted at specified dates. WHO also emphasizes the need to have trained personnel to conduct the cleaning processes. This will ensure the right cleaning agents and equipment are used in the process. Overall, an organization is able to assure quality in its production process (Evans and William 47).

Quality assurance is one of the components of quality management. This ensures that there are systems that proactively define processes. This leaves no room for errors and defective products. One of the factors that aid in reducing defects includes understanding the process. If technicians understand, the standard operating procedure for cleaning equipments there will be lesser errors moving towards zero defects. Most defects are caused by human errors that may include forgetfulness, misunderstanding, wrong identification, snowlines, and ignorance. Organizations do their level best to avoid defects, as they are costly. The costs of defects include scrap, rework, warranty costs, inspection costs, and legal suits filed by aggrieved parties. These costs imply that the organizations revenues are utilized more.

This affects the bottom line of an organization. There are quality standards guidelines given by the international Standards Organization (ISO). They guide and organization towards zero defects in its processes. After cleaning recommendations can be made on the process and scored on a score sheet. If the process is above average then the equipment is safe. If it fails to meet the average score then a review on the cleaning process can be conducted to ascertain the quality. It is vital to note that a mistake in the mixing of a product may be discovered much later when many batches of a product have been packed already. To avoid waste measures should be taken to follow provided guidelines in processes. Failure to do so results in duplication of defects throughout a process. There are companies that with draw a whole range of products produced in certain periods due to defects. This is normally costly in terms of revenue and image of an organization. Millions are paid in compensation, refunds, and replacement of products. It is prudent to get it right at the very beginning to avoid the consequences (Evans and William 32).

Works Cited

Evans, James, and William Lindsay. The management and control of quality, 5^th ed. The University of Michigan: West Pub. Co. 2002. Print

Tekchandaney, Jayesh. V-Blenders. 2009. Web.

Purpose

V-blenders are used mostly in pharmaceutical companies. The blender is the key played in the mixing process of various components used in the production of drugs. The paper aims to present a standard procedure to be used in cleaning the V-blender. This will ensure that the components produced meet quality standards. There will be defective products from contamination from other components from the V-blender (Tekchandaney 2).

Scope

This information applies to all individuals who may use the V-blender at some point in the production process. This aids in the cleaning of the blender. Care should also be taken to ensure the surrounding and components to be mixed are not contaminated.

Definitions of words used in the paper

• IPA means Isopropyl alcohol
• Approved detergents  are detergents that have been recommended for cleaning by the facility and specified for the V- blender
• Harmful chemicals  this are substances that when exposed or released to the environment may alter the natural state the environment that might result to destruction of the flora and fauna and harm the human population

List of equipment used in cleaning the V-blender

1. Gallons of well-labeled plastic buckets
2. Disposable wipes
3. Purified wipes for cleaning to ensure sterility of the gasket
4. Brush and long handle mobs
5. Specific vacuum cleaner for the gasket
6. Water hoses clearly labeled for the purified water, cold and hot purified water
7. Specialized flash light for observation after cleaning

Cleaning solutions

1. Approved detergents for the purpose at hand
2. 70% IPA used to sanitize the V-blender
3. Distilled water

Responsible persons

There should be at least two technicians assigned to clean the V-blender. They should be well trained and approved by the relevant bodies in the pharmaceutical industry. This ensures there is professionalism and minimizes the likelihood of defective drugs.

Procedure

1. Tag the equipment with a cleaning label, indicating not in used.
2. The technicians ensure they have the required protective clothing before the start of the process
3. Disconnect the power cable and remove the lid
4. Remove any visible materials from the blender (gasket) and place them in disposable sterile bags. This ensures that they are not disposed dangerously. They can be harmful chemicals to the people and the environment.
5. Cleaning the gasket starts by using a long handle mob
6. Spray the gasket with hot purified water and close the lid. Switch on the power and run the blender on a low knob to mix the detergents and cleaning agents.
7. Discard the contents using the discharge valve.
8. Use the brush to remove any residual remaining in the gasket
9. Fill the gasket with cold water and run the blender again on a low knob
10. Discard the contents using the lower valve.
11. Use the flashlight to check if there is any residual remaining in the gasket. If there is any residual, the procedure is repeated from step 5.
12. After ensuring that there is no residual, fill the gasket with 10 USG of IPA using the plastic gallons. Close the gasket and run the blender on a low knob again to ensure the solution covers the entire surface.
13. Drain the solution
14. Wipe the exterior part that may have been exposed to the cleaning agents or solutions using disposable wipes.
15. Then use the purity wipes to wipe the inside of the gasket. This is to remove the IPA solution.
16. Allow a 30 minutes window before closing the lid of the blender.
17. Collect the disposable wipes and sterile bags drop them in the allocated garbage bins.
18. Clean the brush, gallons, and mobs, and then wipe the floor dry from any liquid or detergent.
19. Ensure that the cleaning equipment and remaining solutions and detergents are returned to their correct storage area. This will avoid any mixing and ease of access by other users.
20. Inspect the V-blender from any defaults. This may be from rust leaking breakages of spillage. A standard form is t filled, signed, and handed to the housekeeping manager. This is critical for referencing, inspection, and audit in case any issue arises.
21. Remove the protective clothing and hand over to housekeeping for cleaning.

References to Standards, Manuals or relates Standard Operating Procedure

The World Health Organization (WHO) provides some cleaning validation for equipments. This is to ensure that there is no contamination of products. WHO also stresses the need of using soluble detergents so as they do not leave residual on the cleaned surfaces. There is also need for a standard cleaning procedure for equipments. The process is documented to show evidence that there was cleaning on a certain date. An organization can choose to have routine cleaning exercises on major cleaning conducted at specified dates. WHO also emphasizes the need to have trained personnel to conduct the cleaning processes. This will ensure the right cleaning agents and equipment are used in the process. Overall, an organization is able to assure quality in its production process (Evans and William 47).

Quality assurance is one of the components of quality management. This ensures that there are systems that proactively define processes. This leaves no room for errors and defective products. One of the factors that aid in reducing defects includes understanding the process. If technicians understand, the standard operating procedure for cleaning equipments there will be lesser errors moving towards zero defects. Most defects are caused by human errors that may include forgetfulness, misunderstanding, wrong identification, snowlines, and ignorance. Organizations do their level best to avoid defects, as they are costly. The costs of defects include scrap, rework, warranty costs, inspection costs, and legal suits filed by aggrieved parties. These costs imply that the organizations revenues are utilized more.

This affects the bottom line of an organization. There are quality standards guidelines given by the international Standards Organization (ISO). They guide and organization towards zero defects in its processes. After cleaning recommendations can be made on the process and scored on a score sheet. If the process is above average then the equipment is safe. If it fails to meet the average score then a review on the cleaning process can be conducted to ascertain the quality. It is vital to note that a mistake in the mixing of a product may be discovered much later when many batches of a product have been packed already. To avoid waste measures should be taken to follow provided guidelines in processes. Failure to do so results in duplication of defects throughout a process. There are companies that with draw a whole range of products produced in certain periods due to defects. This is normally costly in terms of revenue and image of an organization. Millions are paid in compensation, refunds, and replacement of products. It is prudent to get it right at the very beginning to avoid the consequences (Evans and William 32).

Works Cited

Evans, James, and William Lindsay. The management and control of quality, 5^th ed. The University of Michigan: West Pub. Co. 2002. Print

Tekchandaney, Jayesh. V-Blenders. 2009. Web.

The Studied Gene-Drug Interaction

Long-standing opioid maintenance is largely the cost-effective method of dealing with reliance on an opioid. Then again, the nontoxic and successful utilization of replacement opioids, for example, methadone depends on an immense deal on the best dosage that lessens withdrawal and unpleasant opioid side effects, and simultaneously cuts down the use of heroin. The thin therapeutic index and disparities in individual response to drugs further complicate this treatment process. According to Barratt, Coller, Hallinan, Byrne, White, Foster, and Somogyi (2012), Australia witnesses high incidences in methadone maintenance plans notwithstanding the personalized treatment tactics it employs (comparison of the patients indications and the dosage of drug). For this reason, a profound comprehension of factors lying behind personal reactions to methadone is of extreme consequence. Such knowledge is helpful in enhancing treatment and enriching clinical effectiveness.

There is genetic inconsistency in the ABCB1 gene, which encodes the P-Glycoprotein efflux carrier (Barratt et al., 2012). This gene is associated with changes in the doses needed to maintain methadone levels during therapy. Previous studies indicate proof of a possible interaction between OPRM1 (encodes the receptor of the mu opioid) and ABCB1 to influence reaction to morphine in a contradictory manner (Barratt et al., 2012). This research aspires to establish if such gene to gene relation transpires for methadone during methadone maintenance therapy.

Study Design and Conclusions

The study subjects 119 individuals who depend on opioids to a genotypic examination to test for the presence of five single nucleotide polymorphisms of the gene ABCB1 and OPRM1. These are the 61A>G, 1199G>A, 1236C>T, 2677G>T, and 3435C>T, in addition to OPRM1 118A>G (Baratt et al., 2012). The study uses polymerase chain reaction in determining the genotypes. Restriction fragment length polymorphism is then carried out. According to Barratt et al., Polymerase chain reaction-restricted fragment length polymorphism (PCR-RFLP) spots the 2677G>T via the Cascorbi et al. technique (2012). An agarose gel electrophoresis assists in the visualization of the digested portions. For OPRMI, the 118A>G phenotype utilizes allele-specific polymerase chain reaction. The original case study records provide patient information on dose, pharmacokinetics, and demography. Noteworthy differences unrelated to glycoprotein P have a likely effect on absorption, distribution, breakdown, and removal of methadone. For this reason, the research also investigates the trough plasma (R) methadone concentrations (Ctrough ng/mL) (Barratt et al., 2012).

The research identifies 84 subjects with Ctrough data and includes them in pharmacokinetic scrutiny. Utilization of the Chi-square tests obtains genotype deviations from the Hardy-Weinberg equilibrium whereas version 1 of the PHASE software suggests the ABCB1 haplotypes from genotype data (Barratt et al., 2012).

The frequencies of OPRMI1 and ABCB1 fall within the Hardy-Weinberg equilibrium of Pe0.4 (Barratt et al., 2012). The study observes 12 diverse haplotypes out of the 114 haplotypes that it positively establishes. There are no substantial dissimilarities between the wild-type genes and methadone dosages in OPRMI1 and ABCB1 (Barratt et al., 2012).

How this Article Adds to the Body of Knowledge on Pharmacogenetics

Pharmacogenetics studies individual responses to drugs in relation to their genetic constituents (Zdanowicz, 2010). Pharmacogenomic studies hope to augment drug efficiency and get rid of unsolicited side effects of medications in the course of therapy (2010). Previous studies establish the effect of the genetics of metabolic enzymes on the deactivation of drugs. Records of numerous genetic deviations in vital liver enzymes that break down drugs in the early 1970s steer the development of this discipline. Ten outstanding pharmaceuticals and the Wellcome Trust pool efforts to establish 1.8 million Single Nucleotide Polymorphisms (SNPs). According to Zdanowicz, the NIH (National Institutes of Health) found the Pharmacogenetics Research Network (PGRN) with three main aims including scrutinizing the consequences of genetic differences on drug reaction (2010).

This study, therefore, contributes to the achievement of this target by establishing that there is no considerable gene to gene interaction between OPRM1 and ABCB1 genes on the function of methadone. This helps in providing specialized treatment to patients requiring methadone maintenance treatment.

References

Barratt, D. T., Coller, J. K., Hallinan, R., Byrne, A., White, J. M., Foster, D. J. R., & Somogyi, A. A. (2012). ABCB1 haplotype and OPRM1 118A, G genotype interaction in methadone maintenance treatment pharmacogenetics. Pharmacogenomics and Personalized Medicine. 1(5), 53-62. Web.

Zdanowicz, M. M. (2010). Pharmacogenomics: Past, present, and future. In M. M. Zdanowicz (Ed.), Concepts in pharmacogenomics (pp. 3-18). USA: American Society of Health-System Pharmacists Inc.

Introduction

The termination of a trial due to the adverse effects of a drug or agent is one of the most important aspects of clinical studies on drugs and drug agents. Known as a trial close out, the procedure of terminating a clinical trial is the act of ensuring that all the activities related to the clinical trial are reconciled in the appropriate manner, recorded and reported at the abrupt end of the process (Chow & Liu, 2012).

This should be done in accordance with the standard operating procedures, the GCP, as well as any other applicable regulatory requirement (Chow & Liu, 2012). Clinical trial closes out due to adverse effects or any other reason, including participant walkout, is an important step in ensuring the quality of the study according to the requirements by the SOPs, GCP, sponsors and the law (Fortwengel, 2010).

In addition, it is designed to ensure that all the necessary documents are put in place when a need for information retrieval arises in the future. In case of a clinical trial closeout due to adverse effects of the drug or agent, it is the role of the principal investigators (PIs) to ensure that terms and conditions of the trial project and its related budget are in place (Pocock, 2011).

The purpose of this research paper is to carry out an investigate analysis of the closeout procedures due to the adverse effects of an agent designed to lower cholesterol in humans. The drug agent is in its Phase II trial under a double-blind placebo study. However, it has faced problems due to adverse effects on the participants. There is an urgent need to terminate the study.

Clinical trial closeout

For the purpose of quality assurance and protection of information and participants rights, a number of activities are conducted at the end of a clinical trial either due to completion of the project or termination (Friedman, Furberg & DeMets, 2011). All the activities carried out at the end of a study for any reason constitute study closeout (Fortwengel, 2010). One of the main reasons for study closeout is to ensure that the study records are collected in the right manner and archived.

In addition, it ensures that leftover study articles, materials, and equipment are returned to the appropriate party or disposed of (Foresterhill, 2009). It also ensures that any loose end is tied up. In most cases, project sponsors tend to hold up the final payment until a complete closeout has been completed. In Canada, food and drug administration requires proper inspections at the end of a clinical trial.

Indications for a trial closeout: Termination due to adverse effects versus normal closeout

Although the processes of the closeout for a clinical trial follow a common protocol, it is worth noting that a number of differences exist between the processes indicated for a trial closeout due to advise effects and those indicated for a normal closeout.

In case a trial is terminated prematurely due to the adverse effect of the drug or agent on the participants, a number of indications are provided for both the investigators and the sponsors (Foresterhill, 2009). First, the investigators are required to promptly inform the trial subjects and assure appropriate therapy and follow-up on all the subjects. In addition, the investigator should inform the regulatory authorities of the incident and the protocols in use.

This is in contrast to the normal close up of a clinical trial, where investigators are required to provide information on the results of the study. Clinical close up due to completion of the study does not focus on following up or providing any form of therapy to the study subjects (Pocock, 2011).

On the other hand, it is a mandatory requirement that investigators carry out an immediate and comprehensive follow-up on all the subjects exposed to the trial and provide a compulsory therapy to counter the adverse effects of the drug or drug agent in case of an adverse effect on any subject (Friedman, Furberg & DeMets, 2011).

It is indicated that an investigator must inform the institution or authorities, where applicable if they decide to terminate the clinical trial due to adverse effects without a prior agreement of the sponsor (Foresterhill, 2009). It is mandatory for the investigators to inform the relevant authorities, especially Health Canada and Food and Drug authorities, of the incident even prior to the knowledge of the sponsor. A sponsor is then provided with a detailed explanation of the causes and processes of termination of the clinical trial.

On the other hand, closeout procedures due to completion of the study does not have a focus on involving the authorities. Rather, the investigator is required to develop a comprehensive analysis of the procedure and communicate with the sponsor prior to involving the authorities (Chow & Liu, 2012).

Although authorities are provided with frequent updating on the progress of the project, successful completion of a clinical trial mostly leads to some useful information from research, which is likely to be held confidential prior to the final release. As such, the sponsor has a right to obtain the information prior to any other party.

On the other hand, the authorities are required to have full information about any incident of adverse effect on the subjects, which means that the termination of the trial will not progress towards yielding confidential information about the study (Fortwengel, 2010). Thus, the focus is mainly on the health of the subjects who have been exposed to the drug or drug agent.

An additional difference in indication between normal closeout and closeout due to adverse effect is the involvement of the authorities in the process of close up procedures. In this case, the authorities have the right to terminate or suspend a clinical trial in case of availability of adequate information to prove that the trial has some adverse effects on the subjects (Fortwengel, 2010).

In this case, the role of the investigator or the institution carrying out the clinical trial in terminating or suspending the project is outdone by the powers given to the authorities. In such cases, the opinion of Health Canada is the absolute power to terminate the study for protecting the health of the subjects. In this case, the investigator is required to provide a detailed report of the termination or suspension to the sponsor (Fortwengel, 2010).

On the other hand, closeout of the trial due to completion of the project has little, if any, the involvement of the power of authorities in controlling the process. In this case, the investigator or the institution carrying out the trial is responsible for carrying out the entire close procedures, including authorization of recording and reporting of information obtained from the study (Friedman, Furberg & DeMets, 2011).

The authorities are provided with a detailed report of the procedure, especially the health status of the subjects at the end of the project and the steps taken to ensure that their health status is safe after exposure to the drug or drug agent.

Duties and roles of the Principal Investigator, PI

According to the directions given by Health Canada (2013), each site of a clinical trial must have no more than one qualified investigator. However, the restriction does not apply to any sub-investigator at the site. The PI has a huge volume of responsibilities throughout the entire life of a clinical trial. The PI is responsible for the terms and conditions of a research project and its budget. They are required to understand and comply with all the rules of Health Canada and food and drugs administration.

PIs are required to ensure the appropriate qualifications for the trial being carried out prior to the start of the project (Foresterhill, 2009). It is the role of the PI to provide a declaration of any conflicts of interest, information, payment, and other aspects from any other party.

In addition, the PI must maintain a comprehensive list of any duties and responsibilities delegated to other persons with respect to the trial and the qualifications of these individuals in relation to the process and completion of the project. The PIs are also required to demonstrate the possibility of adequate recruitment of subjects for the clinical trial. They are required to show that necessary time to conduct the study under the HC requirements, adequate facility, and staffs are available.

The type of medical care given to the trial subjects is one of the main requirements of HC. It is the role of the PI to ensure that the necessary medical care is provided to the subjects in any event of adverse events experienced during the process or after the trial. The PIs have the responsibility of processing a favorable HC endorsement of the protocol prior to the commencement of the project.

Patient information and consent, procedures of subject recruitment, and consent updates are mandatory documents that should be provided and maintained by the PIs (Fortwengel, 2010). It is the role of the PI to ensure that the approved protocol is followed throughout the procedure, with additional responsibility of reporting any form of deviation from the protocol. In addition, any deviation from the approved protocol must take place with the endorsement of the relevant authorities.

Roles of the Sponsor

The sponsor is an organization or an individual who oversees the clinical study. The sponsors have a number of roles in any clinical trial. They are responsible for the implementation of quality assurance and quality control protocols. In turn, this ensures that clinical trials are conducted in the right manner, data is gathered, and reporting is done according to the approved protocol (Foresterhill, 2009).

In addition, it is the role of the sponsor to ensure that medical expertise is available for patient care and trial-related medical issues. The sponsor is the main party required to develop the trial design and analysis of the procedure. Data is an important aspect of any clinical trial. The sponsor must ensure that data collection, handling, recording, and overall management of the trial information is done according to the approved protocols.

The process of selecting the appropriate investigators and institutions for conducting the clinical trial is the duty of the sponsor. The process of providing the appropriate assurance and indemnity for the subjects and staff is under the responsibilities of the sponsor (Frank, 2008). The sponsor must also evaluate the safety of the ongoing process throughout the project lifespan.

Responsibilities of the coordinator

The study coordinators (SCs) are hired to direct and organize a clinical trial. However, there are some differences between the roles of the SC and the PIs. While the PIs are responsible for the study, the SCs are assigned the duties of coordination of the process (Foresterhill, 2009). The major role of the SC is to protect human subjects in any trial.

They are responsible for ensuring that the relevant authorities approved the study and all the consent documents provided to the subjects. In addition, the SC has the role of ensuring that the consent process is complete, with the patients answering all the questions. The SC must ensure that the consent is done in the right manner to protect individuals from coercion (Frank, 2008).

Key components of a closeout a monitoring report

A written report should be provided and submitted to the sponsor and the relevant authorities during the closeout phase of a clinical trial (Foresterhill, 2009). The report has a number of key components. The report must specify the name of the site visited, the date of visit, and the monitors particulars.

The name of the PI and other contacted parties must also be provided. The report should have a detailed analysis of the reviewed contents of the procedure. This section should present the statements the monitor makes at the study site, including the data and any findings made. In addition, the summary must provide a detailed analysis of any deviations from the approved protocols as well as deficiencies noted (Chow & Liu, 2012).

Possible issues that are likely to arise at the study site due to the delay of the closeout

Quite evidently, the termination of a study due to adverse effects of the drug agent on the subjects is the initial step that an investigator should consider when the problem is recorded. It aims at protecting the human subjects from any potential harm caused by the drug or the process involved in the trial. According to Chow and Liu (2012), any failure or delay in carrying out an immediate closeout when the adverse effects are seen is usually likely to result into a number of clinical, legal and ethical issues.

First, clinical issues are the most complicated impacts of delay in closeout during adverse effects. For instance, the continuation of the trial process is likely to increase the rate and consequence of adverse effects on the subjects, especially if there is a delay in providing comprehensive medical care and intervention to the affected individuals (Foresterhill, 2009).

Secondly, the PI is likely to face legal consequences in case there is a delay in reporting or termination of the procedure with adverse effects. It is likely that the PI will be responsible for negligence and irresponsible behavior relating to the public health. In ethics and legal perspectives, the delay in closeout is likely to amount to a violation of the rights of the study subjects (Frank, 2008).

References

Chow, S-C., & Liu, J. P. (2012). Design and Analysis of Clinical Trials: Concepts and Methodologies. Mason, OH: Cengage.

Foresterhill, A. (2009). A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet, 365, 711-22.

Fortwengel, G. (2010). Guide for Investigator Initiated Trials. New York: Karger.

Frank, G. (2008). Current challenges in clinical trial patient recruitment and enrollment. SoCRA Source, 30-38.

Friedman, L. M., Furberg, C. D., &. DeMets, D. L. (2011). Fundamentals of Clinical Trials. New York: Springer.

Health Canada, HC. (2013). Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications. Web.

Pocock, S. J. (2011). Clinical Trials: A Practical Approach. Toronto: Ontario: John Wiley & Sons Canada.

Sun Pharmaceutical Industries Ltd is facilitated by other organizations and industries in a bid to improve the health care services that are offered to the people of India and the United States. Some of the organizations that facilitate Sun Pharmaceutical Industries Ltd include the Indian government which has promoted Sun Pharmaceutical Industries Ltd with the reduction of taxes on all the medical products that are brought into the Country (Vishwanath, 2007).

In addition to that, the Indian government has also been a major player in terms of provision of funds to Sun Pharmaceutical Industries Ltd in a bid to improving the medical services and products that are brought into the country. Another organization that has facilitated Sun Pharmaceutical Industries Ltd is the United Nations that has created laws that protect Sun Pharmaceutical Industries Ltd against huge taxes that are charged by some of the country when importing raw materials (Vishwanath, 2007). This has been a huge milestone for Sun Pharmaceutical Industries Ltd in terms of being able to deliver medical products to the people of India and the United States.

Sun Pharmaceutical Industries Ltd has also been facilitated hugely by the World Health Organization which has been on the forefront in informing them of the type of drugs that they are supposed to buy and bring into India and the United Sates. This has been a huge step for Sun Pharmaceutical Industries Ltd in that they are always kept up to date with all the new developments in the pharmaceutical industry and new drug developments.

USAID has been on the forefront in the facilitation of Sun Pharmaceutical Industries Ltd in providing medical products to the people of India and the United States. Sun Pharmaceutical Industries Ltd has been funded majorly by USAID in a bid to buying drugs and other major medical products for the people of India and the United States. USAID has also helped Sun Pharmaceutical Industries Ltd in buying drugs that combat HIV/AIDS which is one of the leading death-causing diseases in the world (Vishwanath, 2007).

The internet company E-BAY has also been on the forefront in helping Sun Pharmaceutical Industries Ltd to sell their products over the internet to clients. This is a major facilitator in that most of the clients that buy medical products from Sun Pharmaceutical Industries Ltd use the internet and specifically use E-BAY to be able to find and buy the products that they need. E-BAY has also been on the forefront of helping Sun Pharmaceutical Industries Ltd to locate where to buy their products which is very important.

The United States government has also been a key facilitator in that it has put in place laws that cushion Sun Pharmaceutical Industries Ltd from being charged very high taxes with regard to the medical products that they bring into the United States. In addition to that, the United States government has also funded Sun Pharmaceutical Industries Ltd so that it can be able to deliver quality medical products for its citizens (Vishwanath, 2007).

The World Bank has also been a major contributor towards making sure that Sun Pharmaceutical Industries Ltd delivers quality medical products to the people of India and the United States. The World Bank has funded all the major research that Sun Pharmaceutical Industries Ltd has carried out with regard to the development of the medical products (Vishwanath, 2007).

Reference

Vishwanath, S. (2007). Corporate Finance: Theory and Practice. New York, NY: Sage.

Achievement of the Course Outcomes in Nursing

During the last eight weeks, I got a good chance to develop my skills and knowledge in the role of a nurse practitioner in the field of Advanced Pharmacology. As a nurse practitioner, every student has to deal with certain communication modalities and identify their values in Advanced Pharmacology. I was involved in different nursing practice interventions, diagnostic techniques, and pharmacologic therapies which are crucial for patients care.

Many research articles and forums where people share their personal experiences and perceptions of pharmacological practice were used to investigate the pharmacological effects of different drugs under particular situations. For example, the combination of NSAIDs like Ibuprofen and acetaminophen is defined as effective to reduce the level of pain (Rasubala, Pernapati, Velasquez, Burk, & Ren, 2015).

Clinical-patient communication is a crucial aspect even in Advanced Pharmacology because it helps to gather enough information and educate patients and their families on how to use drugs and follow the prescriptions given. (Pun, Matthiessen, Murray, & Slade, 2015). The case studies and the situations observed during the course promote an understanding of pharmacology and its importance in treating people with different symptoms and past histories.

The chosen course has a certain impact on me as it helped to comprehend the essence of MSN Essential IX and clarify the peculiar features of nursing interventions that could influence healthcare outcomes for individuals and systems. The experience shows that nursing practice may have different forms and is characterized by numerous interventions with direct and indirect care components. It is not enough for a nurse to have theoretical knowledge and rely on theories and materials offered during an educational process. It is important to understand how to use the offered material and integrate knowledge into practice.

Now, I know a lot about the indications of different medications and the essential mechanism of action when drugs have to be prescribed. Therefore, I can treat patients and provide them with safe and high-quality care and support (for example, a patient has to be observed during the next hour after taking each dose of new drugs). Nurses should also know that some NSAIDs cannot be offered to people with kidney problems to avoid further complications.

Technology and information literacy competencies play an important role in pharmacological nursing practice. It is necessary to integrate appropriate technologies, consider the needs of patients and the abilities of the medical staff, investigate available resources, and assess educational needs in a short period to improve health care and promote safe and high-quality care. As a nurse practitioner, I was able to use different technology systems that could capture data in regards to the needs established.

Nurses have to learn as much information on drug interactions and reactions as possible to explain possible changes and outcomes to patients. The selection of pharmacological agents for patient care has to be properly developed to help patients solve their health problems and concerns. Lab values and drug algorithms are also important in nursing care. This course helps me identify the importance of a nurse in pharmacology and the necessity to study all drugs and all possible reactions of patients on the chosen drugs. Still, it is not enough for nurses to know what to do. It is also necessary to know how to educate patients and help ordinary people comprehend the basics of pharmacology.

References

Pun, J. K., Matthiessen, C. M., Murray, K. A., & Slade, D. (2015). Factors affecting communication in emergency departments: Doctors and nurses perceptions of communication in a trilingual ED in Hong Kong. International Journal of Emergency Medicine, 8(1), 48. Web.

Rasubala, L., Pernapati, L., Velasquez, X., Burk, J., & Ren, Y. F. (2015). Impact of a mandatory prescription drug monitoring program on prescription of opioid analgesics by dentists. PloS One, 10(8). Web.

Effects of Direct Marketing Pharmaceuticals to Consumers

Direct-to-consumer advertisements of pharmaceuticals first gained popularity in 1997, after FDA created a draft guidance outlining the rules for the advertisement of pharmaceuticals. The company had to provide a summary of the side effects of the product in published advertisements, and only the major risks of the drug in broadcast commercials (Fain and Caleb Alexander para. 2). Direct-to-consumers advertisements became very popular with pharmaceutical companies and peaked at 3.3 billion dollars in spending in 2006 (Fain and Caleb Alexander para. 4). These advertisements quickly became a controversial issue. The main criticism against such ads lies in the lack of medical knowledge of the consumers. Therefore, these consumers can insist on prescriptions inappropriate for their conditions (Fain and Caleb Alexander para. 5).

Direct-to-consumer advertisements can be responsible for a wide range of poor judgments from customers. Consumers are driven to the advertised products in search of efficacy but due to their lack of medical knowledge tend to rely on anecdotes, lay theories combined with various biases and heuristics. A rational decision-making model would assume that consumers would weigh the risks and advantages of these products. On the contrary, people have to make so many decisions in their everyday life that they tend to rely on less accurate decision-making methods (Ilyuk et al. p. 319). Some of these biases are very disconcerting to me, especially the tendency to choose a no pain, no gain approach when assessing side effects and negative reactions to the drug. A consumer might continue to take a drug that is harmful to them because they perceive it as efficacy (Ilyuk et al. p. 315).

Debate around Marijuana

Marijuana has been a controversial drug for decades. The main argument against marijuana centers on its perceived status as a gateway drug. Since the start of medical marijuana legalization in the 1990s, this concern persisted amongst politicians while public opinion became more favorable towards the drug. During a discussion, marijuana is often presented as a stepping stone for heroin use (DeAngelo and Redford p. 3). The rise of heroin use in recent years has coincided with the rise of prescription opioid abuse (DeAngelo and Redford p. 4). Could the more accepting view of marijuana lead to it being a gateway drug for the increasing heroin use? Analysis of the accumulated research found that while the legalization of marijuana leads to its higher use, it could not find any evidence that there is any connection to the increased use of heroin, disproving the notion of marijuana as a gateway drug (DeAngelo and Redford p. 19).

Another point of controversy concerns the use of marijuana among teens, especially in the states where medical marijuana has been legalized. Research indicates that while there was an increase in marijuana use among teens during the mid-2000s  2011 period, legalization of marijuana did not have a statistically significant effect on it (Anderson, Mark et al. p. 23). Personally, these findings leave me leaning in support of marijuana legalization.

Recall and Recognition

Different people can have different preferences for tests. If I have a choice, I usually pick an essay. I find it to be a well-structured way of delivering information as well as a chance to create a clearer memory of the presented information. While writing an essay in class, I use recall to reconstruct all the learned information on the given subject and then organize it into one paper. Nevertheless, recall is not the only way to remember information. I use recognition daily to remember passwords, events associated with songs, and solving of rudimentary puzzles.

Two models of information processing are often recognized: recall and recognition. Recognition utilizes associations between events and objects to access memory related to them; it is considered mostly an unconscious process (Ornstein p. 245). People who prefer multiple-choice tests use this model to remember the right answer utilizing the information presented in the test. On the other hand, recall is used when the event or object is not currently present, relying directly on memory for information (Ornstein p. 245). According to Ornstein development of recognition does not rely on societal needs or surrounding stimuli, and might be determined by genetics, while the development of recall can be more dependent on environmental stimulation (p. 254).

Individualism and Collectivism

Individualism and collectivism can be considered opposites due to differing values they represent. Individualism praises self-reliance and independence while collectivism prioritizes working in groups and compliance. Individualists are more likely to care only for themselves and their immediate family in this perspective, and collectivists divide into ingroups and outgroups, expecting their ingroups to provide security in exchange for loyalty. Both can be presented positively and negatively. For example, a person could be so focused on their goals that they hurt the wellbeing of others; in this case, individualism can be seen as selfish and damaging to society. On the other hand, an individualist could be expected to need less from the government and advance in a career while facilitating a competitive economic environment. Collectivism at its worst can disregard the needs of the people and treat them poorly while exploiting their loyalty but a productive collectivist society is united and promotes solidarity, empathy, and cooperation (Taras et al. p. 217).

Surprisingly, a meta-analytical study found these two ideologies are much more alike than it was previously considered. Due to the way the research of this topic is done the accuracy of their differences is hard to measure. The choice of demographic data, the level of analysis, instruments used to collect data, cultural regions can have a strong effect on the results. It proposes the development of a more unified and quantifiable instrument for research on this topic (Taras et al. p. 234).

The difficulty of Diagnosis and Treatment of Personality Disorders

Personality disorders are quite common in our society. People with personality disorders have problems in interpersonal relationships but often are not aware of them and end up attributing these problems onto others. The research on this disorder is lacking which leads to many people living with an undetected personality disorder. Also, it could be misdiagnosed, and they could be receiving insufficient or even harmful treatment in the result. Premature mortality and suicide are also associated with a personality disorder, making its diagnosis a priority (Tyrer et al. p. 717).

Partially the difficulty of diagnosis is in the fact that a personality undoubtedly exists, but there is no clear definition of what is considered an ordered and disordered personality. The diagnosis has to be made of a disorder that is lifelong or at least of many years duration in interaction with other people is a main element of the disorder. There exists no biological or any other kind of marker for its identification. Lack of awareness from the position of the patient also provides difficulty in diagnosis (Tyrer et al. p. 718). Even if the disorder is diagnosed this lack of awareness can prove difficult to overcome to treat the patient, and the treatments themselves are not well documented except for borderline personality disorder (Tyrer et al. p. 719).

Works Cited

Anderson et al. Medical Marijuana Laws And Teen Marijuana Use. American Law And Economics Review, vol 17, no. 2, 2015, pp. 495-528. Web.

DeAngelo, Gregory, and Audrey Redford. Is Medical Marijuana a Gateway Drug?: The Effect of Medical Marijuana Legalization on Heroin Use Rates. 2016 Annual Meeting, February 6-9, 2016, San Antonio, Texas. No. 229981. Southern Agricultural Economics Association, 2015.

Fain, Kevin M. and G. Caleb Alexander. Mind The Gap. Medical Care, vol 52, no. 4, 2014, pp. 291-293. Web.

Ilyuk, Veronika et al. Efficacy Expectations And Adherence: Evidence Of Consumer Biases And Heuristics In Pharmaceutical Marketing. International Series In Quantitative Marketing, vol 20, 2013, pp. 315-344. Web.

Ornstein, Peter A. Memory Development In Children (PLE: Memory). Hoboken, Taylor And Francis, 2014.

Taras, V. et al. Opposite Ends Of The Same Stick? Multi-Method Test Of The Dimensionality Of Individualism And Collectivism. Journal Of Cross-Cultural Psychology, vol 45, no. 2, 2013, pp. 213-245. Web.

Tyrer, Peter et al. Classification, Assessment, Prevalence, And Effect Of Personality Disorder. The Lancet, vol 385, no. 9969, 2015, pp. 717-726. Web.

Medication efficacy is defined as the ability of a particular drug to produce the anticipated positive effect (Farinde, 2018). It is important to notice that drug efficacy is a variable different from drug effectiveness. Practically, efficacy is determined in clinical trials where medications are tested on subjects, and their effects are compared to one another. At the same time, drug effectiveness is associated with real-world use (Farinde, 2018). In that way, assessing the efficacy of a particular, drug, it could be appropriate to apply descriptive statistics.

There are two main types of statistics that are commonly used in research. The selection of each type depends on the nature and purpose of each particular research project. The major purpose of descriptive statistics is to collect and process data for further presentation (Kalla, 2011). In that way, when it comes to the assessment of medication efficacy, this procedure is carried out in a clinical environment that is quite limited. The range of variables measured is narrow and is focused on the degree of an effect produced by the tested drug. Differently put, the purpose of efficacy assessment goes down to the collection and presentation of data about the performance of a chosen drug during the trial. Further, since efficacy and effectiveness of any given medication are correlated and form a continuous bond, inferential statistics should be applied to assess the effectiveness of medication (Gartlehner, Hansen, Nissman, Lohr, & Carey, 2006). The latter type of statistics is focused on making the appropriate conclusion from the statistical data analysis (Kalla, 2011). As a result, it would use the descriptive data about the efficacy of the drug in question and apply it to the effectiveness criteria.

References

Farinde, A. (2018).Drug action. Web.

Gartlehner, G., Hansen, R., Nissman, D., Lohr, K., & Carey, T. (2006). Criteria for distinguishing effectiveness from efficacy trials in systematic reviews. Rockville, MD: Agency for Healthcare Research and Quality (US).

Kalla, S. (2011). Branches of statistics. Web.

References

Beaver, K. (2003). Healthcare information systems. Boca Raton, FL: Auerbach Publications.

Hogstel, M. O. (2001). Gerontology: Nursing care of the older adult. Albany, N.Y: Delmar Thomson Learning.

Kar, A. (2008). Pharmaceutical drug analysis: Methodology-theory-instrumentation, pharmaceutical assays, cognate assays. New Delhi: New Age International.

Majurski, B. (2004). Health Care Information Systems. Web.

Emerging technologies in pharmacy

The developments that led to the invention of vaccinations and other drugs like antibiotics resulted in improved health and there were reduced loss of lives (Chapman et al 1999, p.1). Emerging technologies indicate that some medical conditions, disorders and diseases can be treated by manipulating the human gene. Although most of the new technology is under research and there is a possibility that they could lead to a cure for incurable diseases with fewer side effects, there are moral concerns due to the processes involved. This essay will discuss Pharmacogenomics, Gene Therapy to treat Disease and Gene Therapy for Cancer Treatment. It will also discuss Stem cells Possibilities of Stem Cell therapy and Overview of cloning ethical issues.

Pharmacogenomics

The American Association for Clinical Chemistry (2011) defines Pharmacogenomics as the study of how drugs are metabolized in the body and the variations in the genes that produce the metabolizing enzymes (p. 1). Genes generate enzymes that are essential for the metabolism of the drug. The metabolism of the drugs is diverse in different individuals and thus doctors will prescribe drugs depending on the rate of metabolism.

People are diverse in metabolism of drugs depending on their weight, age and whether they are taking other drugs. The doctor may adjust the amount or decrease the amount depending on the metabolism. Some drugs are metabolized very fast and fail to perform their function or they are metabolized slowly hence overstay and may cause other problems. Other enzymes may actually make the drug more active or is deactivated by the enzyme.

The patients age is considered when prescribing dosage because metabolism varies in different people in different ages. Besides age, doctors use sex and weight to prescribe drugs, this can be replaced by pharmacogenomics where informed decisions can be made. Another importance of the technology is that correct drugs will be administered. This is because some patients fail to respond to some drugs and end up being given another drug. The dosage is also accurate and reduces adverse effects.

The process of testing takes a few hours. The patient is given a sample of drugs. The enzymes that are tested include The Cytochrome P450 family, N-acetyltransferase, Thiopurine methyltransferase (TPMT) and UDP-glucuronosyltransferase (The American Association for Clinical Chemistry 2011, p. 2).

Challenge lies in the interpretation of results. Patients have many genes which makes the process difficult. Some of the tests available are the gene variants for: UGT1A1, CYP2C9, 29 CYP2D6 and VKORC1 (The American Association for Clinical Chemistry 2011, p. 3).

Gene Therapy to treat Disease

Emerging technology on gene therapy demonstrates that gene therapy can be used to correct genetic disorders, diseases and even cancer as pointed out by the Human Genome Project Information (2009 p.1). Genes are passed on from one generation to another and the new generation can have undesirable disorders and diseases. Gene therapy is a procedure that involves correcting genes that carry disease to reduce the chance of developing the disease.

Gene therapy is done by introducing a gene to perform the task of another gene that is dysfunctional. In other cases a gene can be exchanged with another, or repaired using mutation. Also, abnormal genes can be adjusted to perform the desired function. The gene is introduced using a vector which is a virus that has been adjusted to convey the gene therapy to the body. Other methods for introducing gene therapy are: direct delivery and addition of a 47^th chromosome.

Human Genome Project Information (2009, p. 1) notes that experimental of cases of gene therapy have failed. This is attributed to the fact that gene therapy has a short life. As a result, patients need several gene therapy administrations. Another challenge is the defense mechanism of the immune system. The body immune may hinder the effectiveness of the introduced genes as well as reduce effectiveness in consecutive therapies that follow. Using viral vector pose another danger of causing non existence disease. Mutation of gene may cause the patient to be vulnerable to multigene disorders.

However, the American Society of Gene & Cell Therapy (2011, p. 1) reveals that gene therapy has been successful in treating diseases. Among the genetic disorders treated include Hemophilia, bubble boy disease and Chronic Granulomatus Disorder. Other diseases include Neurodegenerative Diseases, hepatitis, influenza and cancer.

Gene Therapy for Cancer Treatment

To treat cancer the immunity cells are strengthened to prevent and to battle with the cancer cells. Gene therapy is introduced in the body to promote formation of strong cells to support the immunity of the patient and fight cancer cells. Another way used in treatment is the destruction of cancer cells. In some cases, the growth cancer is prevented using the therapy.

Before administering radiotherapy and chemotherapy, gene therapy is placed in the cancer cells to make the treatment more effective. The cells are made to become more sensitive to the process and other cancer treatments. In treatment of cancer, the gene therapy is used to prevent formation of vessels of blood, hence making the growth of cancer impossible American Society of Gene & Cell Therapy (2011).

Stem cells

In their research Chapman Frankel and Garfinkel (1999, p.1) state that stem cells are cells that are capable or reproducing other cell tissues. The National Institute of Health (2009, p. 1) indicate that during the early stages in life stem cells multiply in large numbers. The stem cells replace other cells in the body to perform the function of repair. Stem cells are unique cells as they take different forms which include tissue, body organs and can become special forms.

There are different types of stem cell. They include: Totipotent, Pluripotent and Multipotent stem cells. Totipotent is a type that can lead to creation of a new organism. Pluripotent are stem cells capable of generating body tissue. Multipotent are cells that are much more limited to form specific tissue.

Stem cells are important as indicated by National Institute of Health (2009 p.1). After conception, stem cells enable the formation of all body organs that are essential for the human being. They also replace lost cells in the human body. Stem cell can be used to treat diseases given its ability to multiply into different forms.

There are two types of stem cells namely; embryonic stem cells and somatic stem cells. Embryonic stem cells are obtained from a human embryo while somatic stem cells are taken from mature adults. The stem cells are believed to have a capacity to stay for long generating other cells including specialized cells and body organs (National Institute of Health 2009 p. 2).

Possibilities of Stem Cell therapy

Because of the characteristics of the human stem cells, they can be used in the treatment of a variety of diseases. Stem cells have been used to treat blood cancer patients, leukemia, lymphoma, diabetes among others. In order to conduct the therapy the stem cells can be obtained from blood or the bone marrow (Chapman et al 1999, p. xiii).

Stem cell studies might lead to a breakthrough in the treatment of genetic diseases and other diseases. The embryonic cells can be used to study human development in the formation of different tissues, organs and specialized cells. Such studies will lead to the treatment of birth defects and cancer. When researchers come up with an explanation of the stem cell process of differentiation and also cell division it may be possible to prevent such diseases (National Institute of Health 2009).

Stem cells can be used to examination the effectiveness of drugs on different cells before being introduced to patients. The challenge is to ensure that the conditions are the same while testing for different lines.

The National Institute of Health (2009) mentions that the success in establishing the generation of vital body organs that need to be replaced in the human body will be a breakthrough. There are many patients who need body organs such as liver, kidneys among others. People donate these organs and most often there challenges that include finding and matching with the donor (p. 7).

Overview of cloning its ethical issues

There are moral concerns that arise from the method of obtaining embryonic stem cells. Chapman et al (1999, p.11) reveal that the cells are collected from a fetus five weeks from conception and before eight weeks. Besides loss of fetus life concern is if the act is considered illegal. The other concern is if the helpless fetus can be allowed to grow into a child and a healthy adult in future.

There are who are concerned with the ability of the embryonic cells as being equivalent to the somatic cells. There are unease in the reception of the idea that stem cells from human beings ca develop into a person. This raises alarm that man would take over the task of creating human beings. Concerns are if the created human being or the clone would be natural and if they will be the same as the human beings. Furthermore, developments of the moral issue is those who raise concerns feel that the human cell must be secured Chapman et al (1999, p.12).

Conclusion

Emerging technologies in pharmacy are concerned with the study of genes and their manipulation to cure diseases. Pharmacogenomics assist in determining the right dosage and the right drug for a patient. Gene therapy to treat disease may be more effective to cure diseases in a shorter time and with fewer side effects. Using therapy can stop the development or destroy the cells that cause illness. Manipulation of the gene can be adjusting it, introducing a completely gene or mutation.

Stem cells also can be used to form a cure for the diseases. The study of cell division will make it possible to cure some conditions that need replacement of body organs and tissue. Genetic disorders can be corrected and other diseases which are genetic in nature be treated. Stem cells could lead to cloning have encountered concerns on the moral issue. They include the process of obtaining the stem cells and the possibility of making a clone; if they will be natural.

Reference list

American Association for Clinical Chemistry. (2011). Pharmacogenomics: Predicting Which Drugs Will Work and Which Wont. Web.

American Society of Gene & Cell Therapy. (2011). Gene Therapy for Diseases. Web.

Chapman, A. R., Frankel, M. S. and Garfinkel, M.S. (1999). Stem Cell Research and Applications: Monitoring the Frontiers of Biomedical Research. Web.

Human Genome Project Information. (2009). Gene therapy. Web.

National Institute of Health. (2009). Stem cells Basic: Stem Cell Basics. Web.

National Cancer institute. (2010). Gene Therapy for Cancer: Questions and Answers. Web.