Justification of disintegration testing beyond current FDA criteria using in vitro and in silico models

Drug product performance testing is an important part of quality-by-design approaches, but this process often lacks the underlying mechanistic understanding of the complex interactions between the disintegration and dissolution processes involved. Whereas a recent draft guideline by the US Food and...

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Detalles Bibliográficos
Autores principales: Uebbing, Lukas, Klumpp, Lukas, Webster, Gregory K, Löbenberg, Raimar
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2017
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395276/
https://www.ncbi.nlm.nih.gov/pubmed/28442890
http://dx.doi.org/10.2147/DDDT.S131213

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5395276/
https://www.ncbi.nlm.nih.gov/pubmed/28442890
http://dx.doi.org/10.2147/DDDT.S131213

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