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Bücher Englische Bücher Wissen & Bildung Naturwissenschaft, Medizin, Informatik, Technik Medizin Pharmazie The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
John Geigert (Broschiert, Englisch)
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Beschreibung
"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions… into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed. 213,99 €
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Technische Daten
Erscheinungsdatum
25.09.2012
Sprache
Englisch
EAN
9781461348047
Herausgeber
Springer US
Sonderedition
Nein
Autor
John Geigert
Seitenanzahl
350
Einbandart
Broschiert
Schlagwörter
DNA, Filtration, cell culture, clinical trial, development, drug, drug development, drugs, gene therapy, manufacturing, pharmaceutical, protein, research
Thema-Inhalt
MKG - Pharmakologie
PSB - Biochemie
MQP - Pharmazie, Apotheke
PHVN - Biophysik
Höhe
254 mm
Breite
17.8 cm
Hersteller: Springer, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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