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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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John Geigert

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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.

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, John Geigert

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Rok vydania: 2016
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Titul: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Jazyk: anglicky
Autori: John Geigert
Vydavateľ: Springer / Springer New York / Springer, Berlin
Rok vydania: 2016
Väzba: mäkká
ISBN13: 9781493943999
Štítky: Zdravie & Lekárstvo, Príroda, zvieratá, Technika / Strojárenstvo, Príroda
Hodnotenie: 4,75 z 5
Anotácia: 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.