Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration.

Li, Bing V; Davit, Barbara M; Lee, Christina H; Pabba, Santhosh K; Mahadevan, Chitra; Caramenico, Hoainhon T; Haidar, Sam H; Sanchez, Aida L; Sigler, Aaron W; Stier, Ethan M; Conner, Dale P

Li, Bing V; Davit, Barbara M; Lee, Christina H; Pabba, Santhosh K; Mahadevan, Chitra; Caramenico, Hoainhon T; Haidar, Sam H; Sanchez, Aida L; Sigler, Aaron W; Stier, Ethan M; Conner, Dale P.

Afiliación

Li BV; Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, USA. bing.li@fda.hhs.gov

AAPS J ; 15(1): 10-4, 2013 Jan.

Article en En | MEDLINE | ID: mdl-23054974

Asunto(s)

Equivalencia Terapéutica; Humanos; Estados Unidos; United States Food and Drug Administration

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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Equivalencia Terapéutica Límite: Humans País/Región como asunto: America do norte Idioma: En Año: 2013 Tipo del documento: Article

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