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Drug Development Process:

Clinical Trials are highly regulated.When conducting trials with Investigational Products(Drugs) , Regulatory Authorities(RAs) require Good Clinical Practices(GCP) be followed.

-The GCP guidelines should be followed when generating clinical trial data that are intended o be submitted to Regulatory Authorities.

-The Principles established in GCP guidelines may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

-Regulatory Authorities require that a series of tests designed to identify major toxicities of an Investigational Product be conducted before it can be used in any human studies.

  • Laboratory(Pre-Clinical) testing is conducted In Vitro and In Vivo to evaluate the Pharmacokinetics(PK) and Pharmacodynamics(PD) of the investigational product.
  • These tests explore how the body absorbs, distributes, metabolizes and excretes the investigational product. The results provide long-term and short term safety data.
  • Animal testing is used to study the carcinogenic, mutagenic, and teratogenic effects of the Investigational product, and to research drug and food-drug interactions.
  • Efficacy is also part of the testing process during Pre-Clinical studies.

-Once all of preclinical tests have been completed with the Investigational product, the sponsor can apply for permission to test the drug in humans. Testing in human subjects is called Clinical Research.


Drug Development Stages:

Stage I (Drug Discovery):

Drug discovery can begin with over 10,000 chemical compounds and funnel down to just one that is approved. Very few compounds actually make it to approval/market.

Stage II (Pre-Clinical):

Pre-Clinical, the drug goes through a series of rigorous laboratory trials to test the pharmacology of the compound.. These tests allow drug developers to study the Pharmacokinetics(PK) and Pharmacodynamics(PD) of the compound. They include Invitro, InVivo and animal toxicological trials.

Stage III (Clinical Trials):

The clinical trials stage includes Phase I, Phase II, Phase III and Phase IV studies. Prior to beginning any clinical testing, each clinical trial must be authorized by the responsible regulatory agency and the Institutional Review Board(IRB) / Independent Ethics Committee(IEC). The sponsor must provide Pre-Clinical data, and information about which body system or medical condition this indication is to be used for.

Stage IV (FDA Review):

Even after a new drug gains approved to be marketed and sold, additional fact-finding is required, E.g: are the types and rates of Adverse Events(AE) that occur in people taking the drug similar to what is reported on the product label?

Phase IV studies monitor the drug’s performance in subjects from the general population, using a wider range of investigative sites and (possibly) countries.