ANDA

In the pharmaceutical industry the course is designed to give you the skills that have taken many experienced The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The New Drug Application (NDA) is an application submitted to U.S.FDA for permission to market a new drug product in the United States. The components of any NDA are a function of the nature of the subject drug and the information available to the applicant at the time of submission. The form to use for either NDA or ANDA is Form FDA-356h, Application to Market a New Drug for Human Use or as an Antibiotic Drug for Human Use. The international regulatory authorities under consideration are WHO, USFDA, MHRA, and Australian TGA. The standard institutions give the economical background for development and transferring technologies, ISI, ISO, BISS and ASTM. To legally gather this data on safety and effectiveness in the U.S., the maker must first obtain an Investigational New Drug (IND) designation from FDA.

The present study was aimed to study the requirements of bioequivalence for registration of pharmaceutical products in various countries. 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 generic market. This study gives insight about requirements of bioequivalence with study parameters such as study design, fasting or fed state studies, volunteers recruitment, study dose, sampling points, analytical method validation parameters, moieties to be measured in plasma, 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 these bioequivalence studies are usually manufactured by a sponsor or manufacturer while reference is provided by the government laboratories of respective countries. Sampling points also varies with respect to the regulatory guidelines of these countries. India follows Indian GCP guidelines, South-Africa MCC GCP guidelines and Australia follows ICH GCP guidelines. Criteria of bioequivalence, for India and South-Africa is 90% CI 80-125% for Cmax, AUCt, AUCo-inf. for Australia 90% CI 80-125% for Cmax, hAUCt, AUCo-inf.