Bioequivalence Study in India and South-Africa Country

Author(s)

Shah, D.B., Patel, H.N., Maheshwari, D.G.

Author's Affiliation

Abstract

Bioequivalence (BE) study play a major role in the drug development phase for both new drug products and their generic equivalents, and the reason that attract considerable attention globally. The present study was aimed to study the requirements of bioequivalence for registration of pharmaceutical products in Asian & African Country. It is essential for pharmaceutical industry to study the guidelines of bioequivalence for respective country where industry would like to apply for ANDA and thus want to enter into the generic market. The study gives insight about requirements of bioequivalence with study parameters such as design of study, fasting or fed state studies, volunteers recruitment, study dose, sampling points, pharmacokinetic parameters, criteria for bioequivalence, GCP requirements etc. which are needed for pharmaceutical industry to carry out bioequivalence studies and to file ANDA. Test products for bioequivalence studies are usually manufactured by a sponsor or manufacturer while reference is provided by the government laboratories of respective countries. Sampling points varies with the respect to the regulatory guidelines of these countries. India obey Indian GCP guidelines and South-Africa follow MCC GCP guidelines. Criteria of bioequivalence, for India is 90% CI 80-125% for C_max, AUC_t, AUC_o-inf. and South-Africa 90% CI for 75-133% C_max, AUC_t, 80-125% AUC_o-inf.

Keywords

Bioequivalence, Bioavailability, ANDA, Pharmacokinetics, Pharmacodynamic

Cite This Article

Shah, D.B., Patel, H.N., Maheshwari, D.G. (2015). Bioequivalence Study in India and South-Africa Country, International Journal for Pharmaceutical Research Scholars (IJPRS), 4(1), 269-279.