Role of Pharmacovigilance in Drug Development

Clinical Research is a most knowledge-intensive and interesting field in the pharmaceutical industry.

What is Pharmacovigilance (PV)?

Pharmacovigilance is nothing but a drug safety. It is a scientific method of evaluating, understanding, monitoring and preventing adverse side effect of drug in a medical trial. The word Pharmacovigilance is generated from two words; in that “Pharmakon” is a Greek word which means “medicinal substances” and “Vigilia” is a Latin word that means “to keep watch”.

It is most essential & important function within life science industry. PV is the use scientific methods to identify, track, record & analyze side effects or adverse effects of pharmaceutical products to ensure drug quality & safety.

Role of Pharmacovigilance in Drug Development

In drug development Pharmacovigilance possesses very crucial role, an operational overview of PV begins with safety information gathered from various sources such as clinical trials data, spontaneous reports, intensified ADR reporting literature searches, and safety call centers each of which has potential to create an individual case. Role of Pharmacovigilance in drug development phase is listed below.

1. In Drug discovery

2. In Drug Development

3. In Regulatory Review

4. In Commercialization and marketing

Role of Pharmacovigilance in Drug Development

In drug development Pharmacovigilance possesses very crucial role, an operational overview of PV begins with safety information gathered from various sources such as clinical trials data, spontaneous reports, intensified ADR reporting literature searches, and safety call centers each of which has potential to create an individual case. Role of Pharmacovigilance in drug development phase is listed below.

• In Drug discovery

• In Drug Development

• In Regulatory Review

• In Commercialization and marketing

1. Drug Discovery

In the process of drug discovery in Pharmacovigilance, the first step is to identify an appropriate ‘drug’ target which can be a biomolecule or a protein receptor that is explicitly associated with a disease condition or pathology. After the target has been identified, the next step involves target validation and the confirmation of its role in the disease progression. This is followed by testing of the target against different small molecule compounds to identify lead compounds which can interact with the

target biomolecule and display the potential therapeutic activity either by nullify or slow the disease development. The lead compounds can be identified by screening a library of compounds through various methods, such as high-throughput screening, de novo synthesis, and isolation from the natural products

2. Drug Development

The drug development phase involves stringent testing and optimization of

the selected compounds to identify the ‘drug candidate’ which might be most

effective in terms of safety, toxicity , dosage, and efficacy. For this purpose,

the selected lead compounds are tested in cells (in vitro) and in animals (in vivo) to study their pharmacodynamic and pharmacokinetic properties, which include Absorption, Distribution, Metabolism, Excretion and Toxicity (ADME/Tox) properties. The successful lead candidate must be non-toxic and should have

good bioavailability, can be distributed to the drug target in the body, and can be metabolized efficiently and effectively as well as successfully excreted from the body. This part of the development process is referred to as the ‘preclinical phase’ in which the drug candidate is meticulously examined, optimized, and prepared for testing in humans. This phase is followed by the ‘clinical phase’ of development, in which the efficacy and safety of a drug candidate is scrutinized in patients. This ‘clinical trial’ has 3 phases: Phase 1 perform initial human testing in a small group of healthy volunteers to demonstrate the safety and pharmacokinetics, phase 2 involves testing in a small group of patients to demonstrate the safety, efficacy and pharmacokinetics and phase 3 includes testing a large group of patients to show safety and efficacy of the drug candidate in them since the healthy and sick people have potentially different metabolic patterns for the drugs.

3. Regulatory Review and Approval

The outcome of the ‘clinical trial’ decides whether the drug candidate is safer

and effective enough in treating the disease. At this point, new drug applications (NDA) with all the essential evidence, including quality, preclinical and clinical data collected during development of the drug candidate, are submitted to the relevant regulatory authorities, e.g., the United States Food and Drug Administration (USFDA), which oversees the development, approval, and marketing of drugs. They need to approve the drug applications so that the company can commercialize the drug in their jurisdictions (e.g., a New Drug Application (NDA) in USA, and Marketing Authorization Application (MAA) in Europe)

4. Marketing (Commercialization)

This is the last phase of drug development process in pharmacovigilance. Once the drug has been approved, it is marketed or commercialized. The drug manufacturers need to submit marketing authorization applications in every country in which they want to sell the drug. Following this, post-marketing surveillance is conducted by the manufacturer to continue evaluating the safety and efficacy of the marketed drug, and to better design its further development. These studies are considered as phase 4 clinical trials and are compulsory in some countries, e.g, Japan and Philippines. As the drug is typically targeted to a very large number of patients, the manufacturer is expected to monitor this stage cautiously and submit reports to the FDA. The reports include evidence for medicine-related problems, e.g., treatment failure, adverse reaction, counterfeit/poor quality medicines, drug interactions, or incorrect use. These reports are significant in terms of generating proof of efficacy that will inspire public confidence and trust.