Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and quantitative (Q2) similarity. The present study h...

Descripción completa

Detalles Bibliográficos
Autores principales: Ren, Ping, Chan, Theresa, Yang, Wen-Cheng, Frost, Mitchell, Wang, Yan, Luke, Markham, Kim, Myong-Jin, Lionberger, Robert, Zhang, Yi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10534858/
https://www.ncbi.nlm.nih.gov/pubmed/37765334
http://dx.doi.org/10.3390/pharmaceutics15092366

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10534858/
https://www.ncbi.nlm.nih.gov/pubmed/37765334
http://dx.doi.org/10.3390/pharmaceutics15092366

Ejemplares similares