BIOAVAILABILITY: CRITERIA FOR APPROVING A DRUG PRODUCT FOR MARKETING
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2013, Vol 1, Issue 3
Abstract
FDA ensure that the drug product for marketing should be safe, effective and meet all applicable standards, for this FDA requires bioavailability/pharmacokinetic studies and, where necessary, bioequivalence studies for all drug products (FDA Guidance for Industry, 2003). The U.S. Food and Drug Administration (FDA) define bioavailability as "the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed from a drug product and becomes available at the site of drug action". Generally direct and indirect methods use to assess drug bioavailability. For assessing bioavailability or clinical availability of a drug, its rate and extent of absorption and its first-pass metabolism must be evaluated. The clinical response of the patient or the amount of active drug at the target site of action at different time periods should also be assessed. In order to achieve targeted minimum level for therapeutic or clinical effect, the medical practitioner must understand various contributing factors that could affect the bioavailability. For the scientists, they must also be aware of some essential intrinsic factors that influence the formulation. There are basically three factors, which affect bioavailability physiological factors, physicochemical factors and pharmacological factors.
Authors and Affiliations
Sandhya Singh Faheem Ajmal Ansari Shravan Paswan Rnjan Kumar Sharma Alok Ranjan Gaur
Keywords
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