Good Laboratory Practice Regulations, Rocke, David M.
Автор: Ram Sasisekharan; Sau L. Lee; Amy Rosenberg; Larry Название: The Science and Regulations of Naturally Derived Complex Drugs ISBN: 3030117502 ISBN-13(EAN): 9783030117504 Издательство: Springer Рейтинг: Цена: 20962.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.
Автор: Opie Shaun R. Название: Cannabis Laboratory Fundamentals ISBN: 3030627152 ISBN-13(EAN): 9783030627157 Издательство: Springer Рейтинг: Цена: 8384.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space.
Название: Good laboratory practice for nonclinical studies ISBN: 0367336278 ISBN-13(EAN): 9780367336271 Издательство: Taylor&Francis Рейтинг: Цена: 11482.00 р. Наличие на складе: Поставка под заказ.
Описание: This all-encompassing volume addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings
Автор: Thomas Catalano Название: Good Laboratory Practices for Forensic Chemistry ISBN: 3319097245 ISBN-13(EAN): 9783319097244 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Eight chapters examine current practices in analytical chemistry as well as business practices, guidelines and regulations in the pharmaceutical industry to offer improvements to current practices in forensic chemistry.
Описание: Volume 2 of this set contains the full text of the FDA regulations, EC and IPEC guidelines, and ISO/BSI standards referenced in the checklists furnished in Volume I
Автор: Nema, Sandeep Название: Pharmaceutical Dosage Forms - Parenteral Medications ISBN: 1420086472 ISBN-13(EAN): 9781420086478 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Поставка под заказ.
Автор: Opie Shaun R. Название: Cannabis Laboratory Fundamentals ISBN: 3030627187 ISBN-13(EAN): 9783030627188 Издательство: Springer Рейтинг: Цена: 8384.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Cannabis safety testing is a new investment opportunity within the emerging cannabis market that is separate from cultivation, processing, and distribution, allowing individuals and organizations who may have been reluctant to enter previously a new entry route to the cannabis space.
Автор: Singer, Donald C. , Stefan, Raluca-Ioana , van S Название: Laboratory Auditing for Quality and Regulatory Compliance ISBN: 0367392461 ISBN-13(EAN): 9780367392468 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Identifying current tools, techniques, and approaches for the evaluation of laboratory operations, this reference reviews the latest regulatory standards and auditing practices to test laboratory safety, quality, and performance.
Название: Behavioral Biology of Laboratory Animals ISBN: 0367029235 ISBN-13(EAN): 9780367029234 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Поставка под заказ.
Описание: This 30-chapter volume informs students and professionals about the behavioral biology of animals commonly housed in laboratory and other captive settings. The book will help the reader understand their animals better, refine their care and treatment and improve their well-being, welfare, and wellness.
Автор: Drilling, Stephanie Название: Implementing Quality in Laboratory Policies and Processes ISBN: 1420073044 ISBN-13(EAN): 9781420073041 Издательство: Taylor&Francis Рейтинг: Цена: 145464.00 р. Наличие на складе: Поставка под заказ.
Автор: Chowdhury, Ezharul Hoque Название: Nanotherapeutics ISBN: 1032339993 ISBN-13(EAN): 9781032339993 Издательство: Taylor&Francis Рейтинг: Цена: 7348.00 р. Наличие на складе: Поставка под заказ.
Автор: Echols, M. Scott Samples, Oreta Marie Название: Laboratory manual for clinical veterinary technology ISBN: 1591610516 ISBN-13(EAN): 9781591610519 Издательство: Taylor&Francis Рейтинг: Цена: 8726.00 р. Наличие на складе: Поставка под заказ.
Описание: A lab manual of clinical pathology for veterinary technicians.
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