Автор: LeBlanc, Destin A. Название: Cleaning Validation ISBN: 1032430834 ISBN-13(EAN): 9781032430836 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 р. Наличие на складе: Нет в наличии.
Автор: Pazhayattil Ajay, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Название: Solid Oral Dose Process Validation, Volume Two: Lifecycle Approach Application ISBN: 3030274837 ISBN-13(EAN): 9783030274832 Издательство: Springer Рейтинг: Цена: 10366.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The textbook addresses the lifecycle concepts (Stage 1, 2, 3) of Process Validation. Regulatory bodies such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. Organizations have an opportunity to harmonize and align PV activities for all regulated markets. The concepts discussed provides a direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach. This set is published as a comprehensive solution for solid dose process validation.
Автор: Scotti Название: Drug Target Selection and Validation ISBN: 3030958949 ISBN-13(EAN): 9783030958947 Издательство: Springer Рейтинг: Цена: 17074.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The first book in the newly created book series, Computer-Aided Drug Discovery and Design, focuses on the computational aspects of early drug discovery, drug target identification, and validation.
Описание: Herbal Medicines: Development and Validation of Plant-Derived Medicines for Human Health takes readers on a rational path for development of efficacious medicinal herbal products.
Автор: Pazhayattil Ajay Babu, Sayeed-Desta Naheed, Fredro-Kumbaradzi Emilija Название: Solid Oral Dose Process Validation: The Basics, Volume 1 ISBN: 3030024717 ISBN-13(EAN): 9783030024710 Издательство: Springer Рейтинг: Цена: 12196.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance’s, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.
Автор: Agalloco, James P. Название: Validation of Pharmaceutical Processes ISBN: 0849370558 ISBN-13(EAN): 9780849370557 Издательство: Taylor&Francis Рейтинг: Цена: 30624.00 р. Наличие на складе: Нет в наличии.
Автор: Jurgen Moll; Riccardo Colombo Название: Target Identification and Validation in Drug Discovery ISBN: 1627033106 ISBN-13(EAN): 9781627033107 Издательство: Springer Рейтинг: Цена: 13415.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This Methods in Molecular Biology (TM) book details current procedures for identifying and validating new drug targets. Includes methods and approaches covering biochemical, cell based, in vivo models and translational methods, as well as relevant case reports.
Автор: Huber, Ludwig Название: Validation and Qualification in Analytical Laboratories ISBN: 084938267X ISBN-13(EAN): 9780849382673 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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