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Root Cause Analysis of An Inverse Relationship Between The Ice Nucleation Temperature, Process Efficiency And Quality of A Lyophilized Product.
Korang-Yeboah, Maxwell; Ako-Adounvo, Ann-Marie; Hengst, Leanna; Dong, Xiangyi; Zhang, Shawn; Ma, Lisa; Connor, Thomas O'; Ashraf, Muhammad.
Afiliación
  • Korang-Yeboah M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA. Electronic address: Maxwell.Korang-Yeboah@fda.hhs.gov.
  • Ako-Adounvo AM; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
  • Hengst L; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
  • Dong X; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
  • Zhang S; DigiM Solution LLC, 500 West Cummings Park, Woburn, MA 01801, USA.
  • Ma L; DigiM Solution LLC, 500 West Cummings Park, Woburn, MA 01801, USA.
  • Connor TO; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
  • Ashraf M; Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
J Pharm Sci ; 112(12): 3035-3044, 2023 12.
Article en En | MEDLINE | ID: mdl-37648156
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Análisis de Causa Raíz / Hielo Idioma: En Revista: J Pharm Sci Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Análisis de Causa Raíz / Hielo Idioma: En Revista: J Pharm Sci Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos