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THE PHARMA REVIEW (DECEMBER 2008)

BA/BE Calling: Attention Pharmacists!

Habeeb Ibrahim AR, Babu J, Sandilyan R, Prasad LS and Narmadha Sambasivam

Abstract: Thanks to the clinical research boom, Industry has witnessed many changes from economy to openings. The number of generic players has risen tremendously over years, which lead to the increased emergence of Bioavailability/Bioequivalence (BA/BE) clinical/contract research organizations (CROs). India, the home of most number of FDA approved manufacturing plants outside the US is now moving towards the generic revolution. With more products in the pipeline, the country is poised to consolidate her leading arm. Apart from the reduction of drug costs, generics increase drug use; prevent drug shortages; promote product rationalization and avoid supply disruption. Increased awareness of Good Clinical Practices (GCP) requirements, stronger desire of international acceptability of research done in India has brought favorable changes in the attitude of researchers in India towards human research. Like the multi-centric clinical trials, the number of CROs conducting BA/BE studies is increasing day by day offering plenty of opportunities to healthcare graduates/professionals, particularly for pharmacy graduates. The position in these CROs are promising and challenging with chances of conducting studies for various regulatory submissions. It gives the pharmacy professionals the much needed clinical experience in a country where the pharmacists are focused mainly on the industrial aspects. Transferable skills and the right attitude are much essential for a candidate to fetch an offer in this area. The profiles ranging from volunteer recruitment to report writing are discussed in this article.
 
Introduction
The generic business has blossomed throughout the world mainly because of the FDA initiatives. The recent one among them was the 'GIVE' (Generic Initiative for Value & Efficacy Oct 2007). To introduce a drug product in the generic market (ANDA submissions), the Pharma manufacturer has to essentially submit BA/BE studies. The prime objective of these BA/BE studies are to compare the innovator drug product and the test drug product in terms of bioavailability. In most of the cases, healthy adult volunteers are considered as trial subjects. However, in certain cases, special population (like post menopausal women) and patients are also being recruited. The clinical/contract research organizations (CROs) which conduct these studies are playing major role in the Indian clinical research industry. With the number of CROs are on the rise, the role of health professionals are gaining much importance. In particular, the Pharmacy graduates are considered as vital for the ethical conduct of drug trials. With the sound subject knowledge of pharmacology and physiology, they are the much preferred lot. Emergence of this new area has opened up many ways for pharmacy graduates. This article aims to explore the various functional units, opportunities for pharmacy graduates, the role and responsibilities etc., of the study personnel within these BA/BE CROs.

 

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