Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report.


Journal Article

Regulatory approaches for evaluating therapeutic equivalence of multisource (or generic) drug products vary among different countries and/or regions. Harmonization of these approaches may decrease the number of in vivo bioequivalence studies and avoid unnecessary drug exposure to humans. Global harmonization for regulatory requirements may be promoted by a better understanding of factors underlying product performance and expectations from different regulatory authorities. This workshop provided an opportunity for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on current regulatory issues and industry practices, facilitating harmonization of regulatory approaches for establishing therapeutic equivalence and interchangeability of multisource drug products.

Full Text

Cited Authors

  • Chen, M-L; Shah, VP; Crommelin, DJ; Shargel, L; Bashaw, D; Bhatti, M; Blume, H; Dressman, J; Ducharme, M; Fackler, P; Hyslop, T; Lutter, L; Morais, J; Ormsby, E; Thomas, S; Tsang, YC; Velagapudi, R; Yu, LX

Published Date

  • December 2011

Published In

Volume / Issue

  • 13 / 4

Start / End Page

  • 556 - 564

PubMed ID

  • 21845486

Pubmed Central ID

  • 21845486

Electronic International Standard Serial Number (EISSN)

  • 1550-7416

Digital Object Identifier (DOI)

  • 10.1208/s12248-011-9294-5


  • eng

Conference Location

  • United States