Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 28
Book Description
Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products
Author: Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Guideline for the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
Author: Guideline on General Principles of Process Validation
Author: Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 32
Book Description
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.
Basic Tests for Pharmaceutical Dosage Forms
Author: World Health OrganizationPublisher: World Health Organization
ISBN: 9789241544184
Category : Medical
Languages : en
Pages : 144
Book Description
Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer ProtectionPublisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Guideline for Submitting Samples and Analytical Data for Methods Validation
Author: Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and MedicinePublisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483
Book Description
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Pharmaceutical Manufacturing Handbook
Author: Shayne Cox GadPublisher: John Wiley & Sons
ISBN: 0470259809
Category : Science
Languages : en
Pages : 1384
Book Description
This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.
