Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada-Reference-Cited by-同舟云学术

Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada

Published:2014-11 Issue:5 Volume:22 Page:391-402
ISSN:1319-0164
Container-title:Saudi Pharmaceutical Journal
language:en
Short-container-title:Saudi Pharmaceutical Journal

Author:

Galgatte Upendra C.,Jamdade Vijay R.,Aute Pravin P.,Chaudhari Pravin D.

Publisher

Elsevier BV

Subject

Pharmaceutical Science,Pharmacology

Reference14 articles.

1. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs;Borgherini;Clinical Therapeutics,2003

2. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report;Chen;European Journal of Pharmaceutical Sciences,2011

3. Pharmacokinetic, pharmacodynamic, efficacy, and safety data from two randomized, double-blind studies in patients with asthma and an in vitro study comparing two dry-powder inhalers delivering a combination of salmeterol 50 μg and fluticasone propionate 250 μg: Implications for establishing bioequivalence of inhaled products

4. Study on requirements of bioequivalence for registration of pharmaceutical products in India, South-Africa and Australia;Galgatte;American Journal of PharmTech Research,2013

5. Investigation on the need of multiple dose bioequivalence studies for prolonged-release generic products;Garcia-Arieta;International Journal of Pharmaceutics,2012

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