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A Two One-Sided Parametric Tolerance Interval Test for Control of Delivered Dose Uniformity—Part 2—Effect of Changing Parameters

This article examines the effects of changing parameters in the test which was proposed by the FDA at the October 2005 Advisory Committee meeting for confirming delivered dose uniformity in orally inhaled and nasal drug products. This article is an extension of the characterization study presented i...

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Detalhes bibliográficos
Main Authors: Novick, Steve, Christopher, David, Dey, Monisha, Lyapustina, Svetlana, Golden, Michael, Leiner, Stefan, Wyka, Bruce, Delzeit, Hans-Joachim, Novak, Chris, Larner, Gregory
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2009
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2802172/
https://ncbi.nlm.nih.gov/pubmed/19551519
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-009-9269-3
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