The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Language: en
Pages: 597
Authors: John Geigert
Categories: Science
Type: BOOK - Published: 2023-06-15 - Publisher: Springer Nature

GET EBOOK

Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which ap
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Language: en
Pages: 362
Authors: John Geigert
Categories: Medical
Type: BOOK - Published: 2014-07-08 - Publisher: Springer Science & Business Media

GET EBOOK

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importa
FDA Regulatory Affairs
Language: en
Pages: 466
Authors: Douglas J. Pisano
Categories: Medical
Type: BOOK - Published: 2008-08-11 - Publisher: CRC Press

GET EBOOK

Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, researc
Biopharmaceutics Applications in Drug Development
Language: en
Pages: 416
Authors: Rajesh Krishna
Categories: Medical
Type: BOOK - Published: 2007-09-20 - Publisher: Springer Science & Business Media

GET EBOOK

The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of care
Development and Manufacture of Protein Pharmaceuticals
Language: en
Pages: 479
Authors: Steve L. Nail
Categories: Medical
Type: BOOK - Published: 2012-12-06 - Publisher: Springer Science & Business Media

GET EBOOK

In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources