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

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

Lukas Uebbing,1,2,* Lukas Klumpp,1,3,* Gregory K Webster,4 Raimar Löbenberg1 1Faculty of Pharmacy and Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy and Health Research, University of Alberta, Edmonton, Canada; 2Institute of Pharmacy and Biochemistry, Johannes Gutenberg Uni...

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Bibliographic Details
Main Authors: Uebbing L, Klumpp L, Webster GK, Löbenberg R
Format: Article
Language:English
Published: Dove Medical Press 2017-04-01
Series:Drug Design, Development and Therapy
Subjects:
Dissolution
disintegration
DDDPlus
Quality by Design
product specification
model fitting
Online Access:https://www.dovepress.com/justification-of-disintegration-testing-beyond-current-fda-criteria-us-peer-reviewed-article-DDDT

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https://www.dovepress.com/justification-of-disintegration-testing-beyond-current-fda-criteria-us-peer-reviewed-article-DDDT

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