Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets

As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; however, the number of possible formulation and processing factors that could influence the manufacturing of a pharmaceutical dosage form is enormous obviating form...

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Détails bibliographiques
Auteurs principaux: Fahmy, Raafat, Kona, Ravikanth, Dandu, Ramesh, Xie, Walter, Claycamp, Gregg, Hoag, Stephen W.
Format: Artigo
Langue:Inglês
Publié: Springer US 2012
Sujets:
Research Article
Accès en ligne:https://ncbi.nlm.nih.gov/pmc/articles/PMC3513475/
https://ncbi.nlm.nih.gov/pubmed/22993122
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12249-012-9844-x
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