A carregar...

Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms

Bioequivalence (BE) studies are often required to ensure therapeutic equivalence for major product and manufacturing changes. Waiver of a BE study (biowaiver) is highly desired for such changes. Current regulatory guidelines allow for biowaiver of proportionally similar lower strengths of an extende...

ver descrição completa

Na minha lista:
Detalhes bibliográficos
Publicado no:AAPS J
Main Authors: Lin, Zhongqiang, Zhou, Deliang, Hoag, Stephen, Qiu, Yihong
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2016
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4779102/
https://ncbi.nlm.nih.gov/pubmed/26769249
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-015-9861-2
Tags: Adicionar Tag
Sem tags, seja o primeiro a adicionar uma tag!