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Sterile Product Development

Parag Kolhe, Mrinal Shah, and Nitin Rathore

... US Pharmacopeia provides some additional guidance on how to conduct a sterility assurance failure investigation. Yet, in the author's opinion, nei- ther document provides enough meaningful information to aid one in performing an in ...

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Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations (AAPS Advances in the Pharmaceutical Sciences Series, 6)

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Sterile Product Development: Formulation, Process, Quality and Regulatory Considerations (AAPS Advances in the Pharmaceutical Sciences Series Book 6)

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Length: 590 pages

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