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A REVIEW ON DESIGN, EVALUATION AND NEED OF BIOEQUIVALENCE STUDY

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Author(s): Naveen Sheokand

Journal: Pharma Research
ISSN 0975-8216

Volume: 03;
Issue: 01;
Start page: 150;
Date: 2010;
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Keywords: Innovator Drugs | Generic Drugs | Bioequivalence

ABSTRACT
Generics are of high significance in the countries where intellectual property laws are stringent. Once drug patent expire, monopoly of the innovator comes to end and generic drugs having the same formula as the brand-name drug are marketed at a much lower price. These drugs offer great advantage of being economical, as there is no significant change in the quality of the patient care and huge cost saving. Regulatory authorities Food and Drugs Administration (FDA) and European Medicines Agency (EMEA) insist that generic products should compulsorily be “essential similar” with that of reference product in order to exclude any clinically significant difference. Comparing brand-name drug, the generic drug must have similar composition (same quality and type of active principle), route of administration and therapeutic equivalence (bioequivalence). The design and evaluation of bioequivalence study require the preferred approach is an in-vivo study carried out in healthy volunteers to whom the 2 preparations (generic and innovator) are alternatively administered and also require the cooperative input from pharmacokinetic scientist, statistician, bio-analytical chemists and others.

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