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This book addresses the challenges of quality assurance/quality control (QA/QC) in the biopharmaceutical sector, emphasizing its strategic value in manufacturing. It discusses the need for a graded QA/QC approach from clinical trials to market approval and includes updates on new regulatory guidances and the development of biosimilars and other biologics.
Nákup knihy
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, John Geigert
- Jazyk
- Rok vydání
- 2016
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