Phases of Preclinical Trials in Drug Development

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Introduction

The developments of drugs often undergo various processes before being introduced into the market. One of the processes is the preclinical trials. Preclinical trials are conducted to ascertain the effectiveness of the drug on the treatment of the targeted disease (Mulay, 2001). According to the procedures and regulations governing drug development, preclinical trials are conducted in various stages ranging from the first stage to the third stage of phase.

Each phase has distinct characteristics, activities and requirements as defined by the regulatory bodies. Apart from determining the effectiveness of the drug, pre-clinical trials are conducted to establish any side effects of the new drugs that may cause harm to individuals (Mulay, 2001). In other words, pre-clinical trials are conducted to ascertain the effectiveness, mode of application as well as other clinical aspects of the drug before its administration.

Preclinical trial phases in drug development

In most countries, pre-clinical trials are conducted in three stages or phases. In the first phase, clinical trials are conducted in order to observe the behavior of the new drug in a small sample. In essence, the experiments are conducted using a small population to prove various assertions as well as to establish some aspects of clinical practices during the administration of the drug (Hackshaw, 2011).

In addition, the findings in the first phase inform the procedures as well as activities in the subsequent phases. In other words, some aspects in phase two and three are based on the findings of the first phase. In the second phase, further trials are conducted to provide more data particularly on the safety of the new drug and the way it work to treat the target disease (Mulay, 2001).

The second phase establishes the pharmacological processes as well as the side effects of the drug. In the final phase, the pre-clinical trials are conducted in a larger sample and compare the effects of the drug on the experiment and the standard effect or treatment. The procedure and activities in the third phase is almost a repetition of the first phase. However, the population used for the trials in the third phase is large.

In fact, the researchers and medical practitioners conduct the pre-clinical trials through elaborate experimental processes designed to examine the effect of the drug on the subjects as well as the changes in the behavior due to the effects of the new drug (Hackshaw, 2011).

Every phase in the preclinical trials is intended to give diverse data concerning the treatment process of the new drug. The information required includes, safety, working processes as well as the doses (Spilker, 2000). In essence, preclinical trials are intended to provide more information on the laboratory proof of the underlying hypothesis concerning the application of new drug and treatment processes.

However, before the preclinical trials, the new drug is subjected to the laboratory tests to prove the underlying hypothesis. The laboratory experiments involve testing of theoretical hypothesis on the drug formulation (Mulay, 2001). The laboratory process is always an elaborate process and takes several years to turn theoretical concept into practical treatment. The laboratory experimentations confirm the effectiveness of the new drug. The pre-clinical trials are based on the results from the laboratory experimentations.

Similarities and differences in the first and the third phases in the preclinical trials

As indicated, the first and the third phase are similar in many cases. However, the differences also exist in many fronts. The main aim in the first phase of preclinical trial involves establishing the safety of consumption of new drug (Spilker, 2000). The first phase follows the laboratory experimentation process.

Therefore, the first phase in the preclinical trials is conducted on individuals. The procedures in establishing the effectiveness of the drug in the first phase are similar to the procedures in the third phase. In proving such drugs or treatment, the doctors carry out activities ranging from amassing statistics on the dose, timing as well as the wellbeing of the treatment. The involvements of people in the first phase of preclinical trials enable first-hand treatment or the amalgamation of various therapies (Spilker, 2000).

The activities involved in the first phase of preclinical trials involve the steady amplification of the prescribed amount of drug under study. The gradual increase in the dosage known as dose escalation enables the dosage that produces optimal results without causing harsh side effects. In the process, the patients are initially administered with smaller amounts of the drug dosage (Hackshaw, 2011). In most cases, side effects are not observed in the first administration of the drug to a patient.

The drug has to be applied to several patients in order to establish the side effects. Also included in the first phase of preclinical trials is the method of administering the drug. Investigators establish if the drug is administered orally or injected into the bloodstream. In addition, the fisrt phase establishes the reactions of the drug in the body including the way the drug spread into the body. The prescribed procedures are similar to the third phase and the only difference is the population of the patients being used.

The performances of the first phase of preclinical trials are estimated to last for about a year. In addition, the first phase of preclinical trials often encompasses a minimal number of participants ranging from ten to twenty a distinctive difference with other phases. Further, the first phase offer treatment to individuals’ diseases working against the preceding therapies (Mulay, 2001).

In contrast, the third phase of preclinical trials aims are to undertake comparison measures between the latest therapies portraying potential outcomes when administered to a small number of patients exhibiting a particular ailment and the contemporary care standards of the explicit malady (Hackshaw, 2011).

In addition, the third phase involves gathering of data from a large figure of patients. As a result, the doctors are capable of establishing the effectiveness of the new drug as well as the extent of its side effects on the patients compared to the current standards.

Another important aspect of the third phase of preclinical trials is that the experiments are often carried out as random trials. In essence, investigations on the standard application of the drug are conducted unevenly.

Further, the third phase of clinical trials not only focus on the patients with a specific malady, but also encompass patients of diverse ages, ethnicities and both sexes thereby producing results applicable for a large population sample (Hackshaw, 2011). Given the long timeline in the third phase of clinical trials, large sample or population is required to complete the investigation. In most cases, the sample range between seven hundred to two thousand participants.

Moreover, the success of the drug in the third phase preclinical trial leads to the application to the approval of the drug by the authorized bodies such as Food and Drug Administration (FDA). The approval of the drug due the successes in the preclinical trials shows that the drug can be administered for a precise use.

Investigator brochure

The IB (Investigator’s Brochure) is an all-inclusive document in drug development. Actually, during the drug preclinical trials, the manuscript sums up the body of info acquired in the study. Once the IB is obtained, it is modernized with fresh information. Throughout the entire procedure of drug development, the document (IB) is critically significant (Hackshaw, 2011). The human areas under discussion gathered in preclinical and clinical trials in study of drugs gets Investigator’s Brochure relevant when compiling data.

All through the clinical trials, the investigators obtain essential insights from the IB for the administration of study subjects and study conducts (Hackshaw, 2011). The clinical trial protocol with protection measures and key aspects are set up by the investigator’s brochure. The key aspects may encompass, safety-monitoring procedures, techniques of administration, frequency and dosing intervals, as well as study of drugs.

On the other hand, an IB helps the investigator to clearly comprehend the safety measures, observations, specified examination, adverse reactions, and any possible risks accruing during the clinical trials (Mulay, 2001). In brief, the brochure is a guide and an abstract for the segment of the investigator.

The background knowledge in pharmaceuticals is critical in the investigation process during the third phase of preclinical trials. Moreover, based on the pharmacology and previous human experience of the investigational products, a clinical investigator should be in custody of the guidance (Mulay, 2001). The guide should consider treatment and identification of undesirable drug reaction and probable overdose. The information on the IB must be kept updated through a responsible sponsor.

Contents of the investigator brochure in stage one of the product developments

The investigator brochure explains all the activities taking place in the first phase of the product development. The brochure explains in details the required insights for the management and conduct of the investigators at the preclinical trials (Spilker, 2000). In addition, the brochure explains the study subjects as well as the effects of the drug throughout the first phase of the preclinical process.

The information includes the name of the drug, the development process, the way it works as well as the formula (Spilker, 2000). The specified data regarding the drug are obtained from the results of the laboratory tests. In essence, the investigator brochure in phase one will contain more information about the product. Further, the investigator brochure provides the investigator a summary of the information that guides the trials as well as possible risks and uncertainties that may be encountered during the study (Mulay, 2001).

In fact, the brochure will provide the dose development procedure and the characteristics of the subjects that were used in the first phase of preclinical trial. In addition, the brochure will have detailed information regarding the potential risks or the adverse effects of the drug (Spilker, 2000). Moreover, the information concerning the use of the drug, whether in combination or applied singly will also be contained in the first phase investigator brochure.

In the dose data, the brochure will provide more information on dose escalations and the observed side effects. Since the first phase is critical in the product development, the investigator brochure will contain more information that provides insights in the application of the drug (Hackshaw, 2011). Moreover, information concerning the drug administration will also be contained on the brochure. In addition, the investigator brochure also indicates how the side effects should be treated.

In other words, the investigator brochure contains details on the possible side effects and the manner in which such adverse effects should be countered (Hackshaw, 2011). All the information in the brochure is based on the procedure provided and the results obtained from the trials. In the first phase of the product development, the investigator brochure provides direction on the identification and management on the negative effects of the drug.

Conclusion

The development of new drug undergoes various stages before being authorized to be used. The phase includes preclinical trials, which are conducted to ascertain the effectiveness of the drug. The preclinical trials are in phases.

The first phase of preclinical trials tests the effectiveness and behavior differences of the subjects due to the administration of the new drug in a small sample. Similar aims and procedures are conducted in phase three. However, the third phase requires a large population. The major difference between phase one and phase three is the sample population where the third phase applies the larger sample population.

The investigator brochure is critical in the provision of information during the preclinical trials. Specific to first phase of the preclinical trial, the investigator brochure provide the information concerning the new drug. Besides the product information and the investigation procedures, the first phase investigator brochure contains the information concerning the doses, timings as well as the safety of the product.

References

Hackshaw, A. (2011). A concise guide to clinical trials. Malden, MA: John Wiley & Sons.

Mulay, M. (2001). A step-by-step guide to clinical trials. Burlington, MA: Jones & Bartlett Learning.

Spilker, B. (2000). Guide to clinical trials. Philadelphia: Raven Press.

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