Preparing for FDA Pre-Approval Inspections, Hynes, Martin D.
Название: Preparing for FDA Pre-Approval Inspections ISBN: 0367452715 ISBN-13(EAN): 9780367452711 Издательство: Taylor&Francis Рейтинг: Цена: 9492.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
This Second Edition is an essential guide to preparing for FDA pre-approval inspections--taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. The goal of this book is to help organizations gain rapid regulatory approval.
Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility
Автор: Asif, Erfan Syed Название: Pharmaceutical vendors approval manual ISBN: 1032030887 ISBN-13(EAN): 9781032030883 Издательство: Taylor&Francis Рейтинг: Цена: 13014.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides stepwise guidance on how to evaluate, audit, qualify and approve an active pharmaceutical ingredient (API) and packaging material manufacturer and supplier to enhance the GMP within the industry. The book will also be beneficial for institutions conducting pharmaceutical technology courses in terms of GMP and GLP applications. The Pharmaceutical Vendors Approval Manual provides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements. This book provides a simple, concise and easy to use reference tool covering basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies. It is equally relevant to Quality Assurance officers, Quality Control Analysts, Quality Auditors and other personnel involved in GMP/GLP services in the company. The book will also be beneficial for the institutions conducting Pharmaceutical technology study courses in terms of GMP and GLP applications.This bookprovides readers and front-line health care products manufacturers, R&D management and biotech laboratories all the information they need to know to develop a GMP-oriented industry with trained and skilled personnel and manufacture products that meet GMP and regulatory requirements covers basic quality concepts and the elements of vendor’s assessment, qualification and approval required by the pharmaceutical educational institutions and professional certification bodies provides stepwise guidance on how to evaluate, audit, qualify and approve an API and packaging material manufacturer and supplier to enhance the GMP within the industry
Автор: Gad, Shayne C. Название: Safety Pharmacology in Pharmaceutical Development ISBN: 1439845670 ISBN-13(EAN): 9781439845677 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Поставка под заказ.
Автор: Gad, Shayne C. Название: Safety Pharmacology in Pharmaceutical Development ISBN: 0367381451 ISBN-13(EAN): 9780367381455 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.
Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author's more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail.
The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.
Автор: Guarino, Richard A. Название: New Drug Approval Process ISBN: 1420088491 ISBN-13(EAN): 9781420088496 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Поставка под заказ.
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