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pro vyhledávání: '"Daniel J. Tien"'
Autor:
Patrick Y. Yang, Cary F. Opel, Daniel J. Tien, Andrew W. Snowden, Cerintha J. Hui, Gayle E. Derfus
Publikováno v:
Journal of Biotechnology: X, Vol 2, Iss, Pp-(2019)
Drug manufacturing processes must consistently deliver safe and effective product. A key part of achieving this is process validation utilizing Quality by Design (QbD) principles. To meet process validation requirements, process characterization (PC)