A REVIEW ON BIOAVAILABILTY- BIOEQUIVALENCE STUDIES
B. Ramya Sree
Department of Biotechnology, Sree Vidyanikethan Engineering College, Tirupati
Jyothi M. Joy
Department of Pharmacognosy, Sree Vidyanikethan College of Pharmacy, Tirupati
Bioavailability/Bioequivalence studies are special type of clinical trials conducted to establish that the generic drugs are equivalent to the innovator drugs and mostly healthy volunteers participate in these studies. The volunteers must be enrolled in BA/BE studies only after obtaining a written, informed consent. There are reports that the study subjects often fail to understand the important aspects of the study even after informed consent. Hence this project was executed to assess the knowledge of informed consent among healthy volunteers who participate in BA/BE studies. This BA/BE studies helps to Development of a suitable dosage form for a new drug entity and also for Development of new formulation of existing drugs. This report gives a brief overview on the performance of BA/BE studies.
3 , 2 , 2013
42 - 52