Pharmaceutical Vendors Approval Manual : A Comprehensive Quality Manual for API and Packaging Material Approval, Erfan Syed Asif
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
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: Hynes, Martin D. Название: Preparing for FDA Pre-Approval Inspections ISBN: 0849391849 ISBN-13(EAN): 9780849391842 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Нет в наличии.
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: Нет в наличии.
Автор: Mittal, Bhavishya Название: How to Develop Robust Solid Oral Dosage Forms from Conception to ISBN: 0128047313 ISBN-13(EAN): 9780128047316 Издательство: Elsevier Science Рейтинг: Цена: 8588.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips.
By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.
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: Нет в наличии.
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: Beverly A. Teicher; Paul A. Andrews Название: Anticancer Drug Development Guide ISBN: 146849841X ISBN-13(EAN): 9781468498417 Издательство: Springer Рейтинг: Цена: 20962.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.
Автор: Teicher Название: Anticancer Drug Development Guide. 2ed.2004 ISBN: 1588292282 ISBN-13(EAN): 9781588292285 Издательство: Springer Рейтинг: Цена: 34799.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey provides a step-by-step guide to anticancer drug development from initial design through FDA approval. The authors have included new material on the use of high throughput screening in industry, on specialized in vitro/in vivo procedures employed by the National Cancer Institute (NCI) in preclinical drug evaluations, and on nonclinical testing to support both human clinical trials, as well as trials of biologic oncology products. The chapters on phase I, II, and III clinical trials and on novel phase II clinical trial designs for targeted therapies have been significantly updated, along with those on cancer drug development in Europe, working with the NCI, and the FDA's role in cancer drug development and setting requirements for approval.
Автор: Beverly A. Teicher Название: Anticancer Drug Development Guide ISBN: 1461581540 ISBN-13(EAN): 9781461581543 Издательство: Springer Рейтинг: Цена: 16979.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Experienced cancer researchers from pharmaceutical companies, government laboratories, and academia comprehensively review and describe the arduous process of cancer drug discovery and approval.
Автор: Haider, Syed Imtiaz Название: Quality Control Training Manual ISBN: 1439849943 ISBN-13(EAN): 9781439849941 Издательство: Taylor&Francis Рейтинг: Цена: 26796.00 р. Наличие на складе: Нет в наличии.
Автор: Hout, Sam A. Название: Manufacturing of quality oral drug products ISBN: 1032124733 ISBN-13(EAN): 9781032124735 Издательство: Taylor&Francis Рейтинг: Цена: 12554.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.
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