The second day of the ongoing 30th National Workshop on Clinical Pharmacology,in the department of Pharmacology,PGIMER,Chandigarh,began with the lecture of Prof P L Sharma. He spoke on various issues in multicentre clinical trials. Multicentre clinical trials are conducted according to one common study protocol at several hospitals and across nations as well. The basic purpose of conducting trials at multiple centres is to enrol large number of patients in a short period of time,to have ethnically different population with the same disease so that maximum information can be gathered about the drug action and side effects. He also said that conducting these trials is expensive and would cost the sponsor of the trials in millions.
Later during the workshop proceedings Dr A K Mitra,New Delhi shared his experience and discussed established guidelines on good laboratory practices. He spoke on the need and importance of standard operating procedures and instrument calibration and validation procedures.
Dr Mitra also spoke on bioequivalence studies in his second lecture. Bioequivalence studies are conducted to prove that a new drug product,generic product developed by pharmaceutical company is similar to the available marketed drug product,the innovator product. He explained the requirements as per various drug regulating agencies for bioequivalence demonstrations.
After demonstrating bioequivalence the generic product may get approval from the regulating agencies for marketing after the patent of the innovator product expires.