Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets.

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W.

Afiliação

Claycamp HG; Office of Compliance, FDA Center for Drug Evaluation and Research, Silver Spring, MD, USA.
Kona R; Office of New Animal Drug Evaluation, Food and Drug Administration, Rockville, MD, USA.
Fahmy R; Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy, Baltimore, MD, USA.
Hoag SW; Office of New Animal Drug Evaluation, Food and Drug Administration, Rockville, MD, USA.

AAPS PharmSciTech ; 17(2): 233-44, 2016 Apr.

Article em En | MEDLINE | ID: mdl-26202064

Assuntos

Química Farmacêutica/métodos; Química Farmacêutica/normas; Ciprofloxacina/química; Ciprofloxacina/normas; Comprimidos/química; Comprimidos/normas; Teorema de Bayes; Controle de Qualidade; Projetos de Pesquisa; Medição de Risco/métodos; Tecnologia Farmacêutica/métodos; Tecnologia Farmacêutica/normas

Palavras-chave

Bayesian Monte Carlo simulation; ciprofloxacin and granulation; ciprofloxacin hydrochloride; qualitative risk assessment; quality-by-design (QbD); roller compaction

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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Comprimidos / Ciprofloxacina / Química Farmacêutica Tipo de estudo: Etiology_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Idioma: En Ano de publicação: 2016 Tipo de documento: Article

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