Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling

ABSTRACT: This work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification and continued process verification. The intent of these articles is to provide read...

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Detalles Bibliográficos
Autores principales: Jameel, Feroz, Alexeenko, Alina, Bhambhani, Akhilesh, Sacha, Gregory, Zhu, Tong, Tchessalov, Serguei, Kumar, Lokesh, Sharma, Puneet, Moussa, Ehab, Iyer, Lavanya, Fang, Rui, Srinivasan, Jayasree, Tharp, Ted, Azzarella, Joseph, Kazarin, Petr, Jalal, Mehfouz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373746/
https://www.ncbi.nlm.nih.gov/pubmed/34409506
http://dx.doi.org/10.1208/s12249-021-02086-8

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8373746/
https://www.ncbi.nlm.nih.gov/pubmed/34409506
http://dx.doi.org/10.1208/s12249-021-02086-8

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