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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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