Drug development is a process of bringing a new pharmaceutical drug to the market
after a lead compound has been identified by the process of drug discovery. Regulatory
professionals are involved in each stage of the drug development process. The stages
involved in the drug development process are as follows (Fig. 8.1):
i. Drug discovery and target validation
iii. Investigational new drug application filing
iv. Clinical studies (phase 1, phase 2, phase 3)
v. New drug approval application filing
Because of the different phases involved in the drug development process, a team is
required because no single person is expertise in all fields. This team is a combination
of scientific as well as other discipline professionals. It mainly involves a diverse group
of professionals with different approaches to the development process. The team mainly
Fig. 8.1: Stages of drug development
Drug Development and Non-Clinical Studies 123
Discovery and development group: This group is mainly comprised of scientists
and chemists who are involved in the basic research process. The main work of these
groups is to discover a new molecule that can be set as a target. This group prepare a
drug substance with that new molecule for “drug-screening”. These groups also provide
drug substance for non-clinical and clinical studies.
Non-clinical group: This group is mainly comprised of toxicologists and
pharmacologist having experience in animal studies. The main responsibility of this
group is to identify potential efficacy and toxicity of drug substance in humans by
testing in animal models. The pharmacological and toxicological studies in animals
are done to identify the possible effects on humans. The animal models are developed
with the help of the development group and a clinical group.
Clinical group: This group comprises pharmacologists, doctors, physicians who
have previous experience in human trials. The main aim of this group is to ensure the
safety and efficacy of drug substance by testing it in human subjects. The clinical
methods must be science-based which are proved by statistical methodology and
ethical. The clinical research done by this group can also generate the publications
which are necessary for the marketing of the drug product. Phase 1, 2 and 3 clinical
trials are performed by this group. Clinical researchers are in direct contact with
regulatory authorities and prepare the study reports with the help of biostatisticians
Regulatory group: Regulatory group comprises regulatory professionals. These
professionals are interface with main regulatory authority and responsible for INDA,
NDA filing at an appropriate stage. These professionals also inform various groups
about the guidelines to be followed during the development process.
Marketing group: The main responsibility of this group is to make marketing and
selling processes smoother for the company. Marketing group design product's label
which differentiates their product from other available products in the market.
Marketing groups have to make strategies to satisfy the physicians, patient and senior
management of their company regarding usage, effect and profit of product
Engineering group: This group deals with the technicalities related to maintenance
and improvement of equipment, and other mechanical as well as computerised
resources used during the drug development process. This group is comprised of
electrical engineers, biomedical engineers, software developers, mechanical engineers,
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