A Regulatory Perspective on Manufacturing Processes Pertaining to Lyophilized Injectable Products.

Rhieu, Steve Y; Anderson, David D; Janoria, Kumar

Rhieu, Steve Y; Anderson, David D; Janoria, Kumar.

Afiliación

Rhieu SY; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA. steve.rhieu@fda.hhs.gov.
Anderson DD; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.
Janoria K; Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA.

AAPS J ; 22(5): 100, 2020 08 02.

Article en En | MEDLINE | ID: mdl-32743675

Asunto(s)

Industria Farmacéutica/normas; Legislación de Medicamentos; Industria Farmacéutica/legislación & jurisprudencia; Estabilidad de Medicamentos; Liofilización; Inyecciones

Palabras clave

deficiencies; freeze-drying; injectable; lyophilization; unit operation

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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Industria Farmacéutica / Legislación de Medicamentos Tipo de estudio: Prognostic_studies Idioma: En Revista: AAPS J Asunto de la revista: FARMACOLOGIA / TERAPIA POR MEDICAMENTOS Año: 2020 Tipo del documento: Article

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