The Challenge of CMC Regulatory Compliance for Biopharmaceuticals 1

Kropp & själ

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Name: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Price: 3819 SEK
Availability: InStock
Author: John Geigert
ISBN: 9781461469155

John Geigert

Inbunden

3819:-

Funktionen begränsas av dina webbläsarinställningar (t.ex. privat läge).

Uppskattad leveranstid 7-12 arbetsdagar

Fri frakt för medlemmar vid köp för minst 249:-

Andra format:

338 sidor
2013

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

Författare: John Geigert
Illustratör: 60 schwarz-weiße Tabellen 8 schwarz-weiße und 15 farbige Abbildungen
Format: Inbunden
ISBN: 9781461469155
Språk: Engelska
Antal sidor: 338
Utgivningsdatum: 2013-05-07
Förlag: Springer-Verlag New York Inc.