Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 50
Book Description
Draft Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 50
Book Description
Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Center for Drugs and Biologics (É.-U.)Publisher:
ISBN:
Category :
Languages : en
Pages : 60
Book Description
Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products
Author: Draft Guideline for Submitting Supporting Documentation for the Manufacture of Finished Dosage Forms
Author: United States. Food and Drug AdministrationPublisher:
ISBN:
Category : Drugs
Languages : en
Pages : 18
Book Description
Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
Author: Peptide Therapeutics
Author: Ved SrivastavaPublisher: Royal Society of Chemistry
ISBN: 1788014332
Category : Science
Languages : en
Pages : 572
Book 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.
Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics
Author: Draft Guideline for Submitting Supporting Chemistry Documentation in Radiopharmaceutical Drug Applications
Author: Center for Drug Evaluation and Research (U.S.)Publisher:
ISBN:
Category : Radiopharmaceuticals
Languages : en
Pages : 47
Book Description
Guideline for Submitting Documentation for Packaging for Human Drugs and Biologics
Author: Publisher:
ISBN:
Category : Drug packaging industry
Languages : en
Pages : 44
Book Description