FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus

The qualification process for ensuring that a paddle or basket apparatus is suitable for its intended use is a highly debated and controversial topic. Different instrument qualification and suitability methods have been proposed by the pharmacopeias and regulatory bodies. In an effort to internation...

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Main Authors: Brown, Cynthia K., Buhse, Lucinda, Friedel, Horst-Dieter, Keitel, Susanne, Kraemer, Johannes, Morris, J. Michael, Stickelmeyer, Mary, Yomota, Chikako, Shah, Vinod P.
Format: Artigo
Sprog:Inglês
Udgivet: Springer US 2009
Fag:
White Paper
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC2802143/
https://ncbi.nlm.nih.gov/pubmed/19609681
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-009-9291-5
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