A Comprehensive Review on Bioequivalence Studies in Human Subjects
Journal Title: Journal of Pharmaceutical Research International - Year 2016, Vol 11, Issue 2
Abstract
Aims: Purpose of the current review was to provide information about the bioequivalence and the bioequivalence study steps in human subjects to conduct bioequivalence studies easily as well as to increase the use of alternative generic products and to decrease the healthcare cost. Methodology: For this review different research and review articles were studied. The steps of bioequivalence studies on human subjects were closely understood. Bioequivalence gained increasing attention during the last 3 decades after it became clear that marketed products having the same amounts of the drug may exhibit marked differences in their therapeutic responses, which is making difficulties for physicians and pharmacists for choosing therapeutically equivalent drug for patient. Generally, these differences were caused mainly by impaired absorption. Now a considerable body of evidence has accumulated indicating that drug response is better correlated with the plasma concentration or with the amount of drug in the body than with the dose administered. Consequently, on the basis of simple pharmacokinetic concepts and parameters, bioavailability and bioequivalence studies have been established as acceptable surrogates for expensive, complicated and lengthy clinical trials and are used extensively worldwide to establish and ensure consistent quality and a reliable, therapeutically effective performance of marketed dosage forms. Conclusion: This study provides the basic information and specifications which are required to fulfill while performing the bioequivalence studies.
Authors and Affiliations
Muhammad Zaman, Sherjeel Adnan, Ali Aun, Muhammad Uzair Yousaf, Ayesha Naseer, Maryam Shareef
Keywords
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- EP ID EP342491
- DOI 10.9734/BJPR/2016/23976
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