Clinical Development

About one in 1000 NCEs reach this stage. The steps to be studied in this stage include:

a) Pharmaceutical study
b) Pharmacological study
c) Clinical trial.

a) Pharmaceutical study covers stability of formulation and compatibility of the NCEs with other tablet or infusion ingredients.
b) Pharmacological study includes further chronic toxicological study in animal, initially animal metabolic and pharmacokinetic study. When studies in animals predict that a NCE may be useful medicine i.e. effective and safe in relation to its benefits, then the time has come to put it to the test in man i.e. clinical trial.
c) Studies on human or Clinical Trial:
Clinical trial is a means by which the efficacy of drug is tested on human being. It may also give some idea about the risk involved. It is divided into 4 phases. With each phase, the safety and efficacy of the compound are tested progressively.
Phase – I: This is the first exposure of the new drug on man which is usually conducted in healthy volunteers and which is designed to test the tolerable dose, duration of action. This phase is usually carried out in only one centre on 20 to 50 subjects.
Phase – II: This phase comprises small scale trials on patients used to determine dose level and establish that the treatment offers some benefit. It usually involves 100-500 patients and is usually conducted in several centres.
Phase – III: Full scale evaluation of treatment comparing it with standard treatment is done in this phase. It involves randomised control trials on 250 to 2000 patients and is done in multiple centres. Information from all studies are received by the “Committee of safety of medicines” (CSM). If the drug is satisfied by the CSM, the product license is issued then the drug is marketed.
Phase – IV: It is also called as phase of post marketing surveillance. Reports about efficacy and toxicity are received from the medical practitioners and reviewed by the committee of review of medicines. Renewal or cancellation of the product license depends on the comment of the review committee.