The estimation of safety and tolerability with initial administration of an investigational new drug(s) into human subject, GBCRA has the objectives of demonstration or confirmation of therapeutic benefits. Studies in phase-III are designed to confirm the preliminary evidence accumulated in phase-II, that a drug is safe and effective for use in the intended indication and recipient population subject to the approval of the Ethical Committee. This study includes the dose response, drug concentration in blood and clinical response.
Phase-III study also includes, the drug(s) approved outside the country, as the licensing authorities very often may require Pharmacokinetic studies to be undertaken afresh to verify that the data generated in our country is in conformity with the data already generated in abroad.
The Process
Kolkata, West Bengal, India.
