Open AccessParameters to be Considered in A Bioequivalence Study of Drug
Author(s) -
Nilesh Chougale
Publication year - 2021
Publication title -
international journal for research in applied science and engineering technology
Language(s) - English
Resource type - Journals
ISSN - 2321-9653
DOI - 10.22214/ijraset.2021.37638
Subject(s) - bioequivalence , drug , pharmacokinetics , bioavailability , pharmacology , medicine , crossover study , pharmacodynamics , generic drug , alternative medicine , pathology , placebo
Bioequivalence is a word used to describe the biological equivalency of two proprietary medication preparations. When two medications are bioequivalent, it indicates they are expected to be the same. Pharmacokinetic studies are used to determine bioequivalence between two medications, such as a reference drug (FDA approved drug) and a potential test drug (marketed generic drug), by administering each drug to volunteers in a cross-over research (healthy individuals). To prepare a drug many aspects need to take into consideration such as in vivo and in vitro study, pharmacokinetics, pharmacodynamics and bioavailability of the drug. While designing a drug fasting, oral, crossover study of the drug needs to perform.