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Peptide Therapeutics on Hardback
Peptide Therapeutics on Hardback
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Peptide Therapeutics

Strategy and Tactics for Chemistry, Manufacturing, and Controls
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Description

Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
Release date NZ
August 28th, 2019
Audiences
  • Professional & Vocational
  • Tertiary Education (US: College)
Contributor
  • Edited by Ved Srivastava
Pages
571
ISBN-13
9781788014335
Product ID
29025717

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