Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 68
Book Description
Guideline for Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances
Author: Guideline for Submitting Documentation for the Manufacture of and Controls for Drug Products
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 the Format and Content of the Chemistry, Manufacturing, and Controls Section of an Application
Author: The Use of Drugs in Food Animals
Author: National Research CouncilPublisher: National Academies Press
ISBN: 0309175771
Category : Medical
Languages : en
Pages : 276
Book Description
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
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.
Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics
Author: Publisher:
ISBN:
Category : Biological products
Languages : en
Pages : 76
Book Description
Approved Prescription Drug Products with Therapeutic Equivalence Evaluations
Author: Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 336
Book Description
Accompanied by supplements.
Dietary Supplements
Author: United States. Federal Trade Commission. Bureau of Consumer ProtectionPublisher:
ISBN:
Category : Advertising
Languages : en
Pages : 32
Book Description
Handbook of Stability Testing in Pharmaceutical Development
Author: Kim Huynh-BaPublisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
Book Description
This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
