Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications

Dissolution profile comparisons are used by the pharmaceutical industry to assess the similarity in the dissolution characteristics of two formulations to decide whether the implemented changes, usually minor/moderate in nature, will have an impact on the in vitro/in vivo performance of the drug pro...

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Vydáno v:AAPS J
Hlavní autoři: Suarez-Sharp, Sandra, Delvadia, Poonam R., Dorantes, Angelica, Duan, John, Externbrink, Anna, Gao, Zongming, Ghosh, Tapash, Miksinski, Sarah Pope, Seo, Paul
Médium: Artigo
Jazyk:Inglês
Vydáno: Springer US 2016
Témata:
Review Article
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC5256611/
https://ncbi.nlm.nih.gov/pubmed/26928450
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-016-9893-2
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