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

Autor: Jennifer B. Dressman, Paul Fackler, Leon Shargel, Terry Hyslop, Saji Thomas, Henning Blume, Yu Chung Tsang, Murray Ducharme, Mei-Ling Chen, Lorelei Lutter, Dennis Bashaw, Lawrence X. Yu, Masood Bhatti, José A.G. Morais, Eric Ormsby, Vinod P. Shah, Raja Velagapudi, Daan J.A. Crommelin

Publikováno v: Repositório Científico de Acesso Aberto de Portugal
Repositório Científico de Acesso Aberto de Portugal (RCAAP)
instacron:RCAAP

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 avoi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e262b8bf91c60b433e0fb7b67de9616b
https://pubmed.ncbi.nlm.nih.gov/21946259