Pharmaceutical Engineering Change Control, Turner, Simon G.
Автор: Shah B. Название: Textbook Of Pharmacognosy And Phytochemistry 2Ed ISBN: 9386217732 ISBN-13(EAN): 9789386217738 Издательство: CBS India Рейтинг: Цена: 5487.00 р. 7838.00-30% Наличие на складе: Есть (1 шт.)
A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals
Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates--especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors--into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry.
This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book.
Topics covered include:
Drug Approval Process and Regulatory Requirements (private standards)
Pharmacopeias and Compendial Approval Process (public standards)
Common methods in pharmaceutical analysis (typically compendial)
Common Calculations for assays and impurities and other specific tests
Analytical Method Validation, Verification, Transfer
Specifications including how to handle out of specification (OOS) and out of trend (OOT)
Impurities including organic, inorganic, residual solvents and elemental impurities
Good Documentation Practices for regulatory environment
Management of Analytical Laboratories
Analytical Instrument Qualifications including IQ, OQ, PQ and VQ
Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted.
Pharmaceutical Analysis for SmallMolecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.
Описание: Intends to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. This book emphasizes on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target.
Название: Pharmaceutical Engineering Change Control ISBN: 036739474X ISBN-13(EAN): 9780367394745 Издательство: Taylor&Francis Рейтинг: Цена: 10411.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. The author covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate that a change control system is working, the book includes chapters on computer validation and customization of the change process to each project's needs. Case histories and anecdotes illustrate key points and provide a basis for change control training. The book gives readers a toolbox for ensuring that adequate controls are implemented.
Автор: Pandey, Ravindra Kumar (associate Professor, Department Of Natural Products, Columbia Institute Of Pharmacy, India) Shukla, Shiv Shankar (associate Pr Название: Fingerprinting analysis and quality control methods of herbal medicines ISBN: 1138036943 ISBN-13(EAN): 9781138036949 Издательство: Taylor&Francis Рейтинг: Цена: 19140.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Due to the increase in the consumption of herbal medicine, there is a need to know which scientifically based methods are appropriate for assessing the quality of herbal medicines. Fingerprinting has emerged as a suitable technique for quality estimation. Chemical markers are used for evaluation of herbal medicines. Identification and quantification of these chemical markers are crucial for quality control of herbal medicines. This book provides updated knowledge on methodology, quality assessment, toxicity analysis and medicinal values of natural compounds.
Автор: Jimenez, Luis Название: Microbial Contamination Control in the Pharmaceutical Industry ISBN: 082475753X ISBN-13(EAN): 9780824757533 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Explores, through innovative studies, case studies, systematic literature reviews, and reports, the key developments in digital entrepreneurship, circular economy and digitalization, digital business models, digital marketing and internationalization, digital economy, digital learning, trends and challenges, and digital entrepreneurial ecosystems.
Автор: Haider, Syed Imtiaz Название: Quality Control Training Manual ISBN: 1439849943 ISBN-13(EAN): 9781439849941 Издательство: Taylor&Francis Рейтинг: Цена: 28327.00 р. Наличие на складе: Нет в наличии.
Описание: The Handbook of Microbiological Quality Control provides a unique distillation of material by providing a wealth microbiological information not only on the practical issues facing the company microbiologist today, but also the underlying principles of microbiological quality assurance. The book provides guidance on safe microbiological practices, including laboratory design and sampling techniques, and considers the design storage, use and quality control of microbiological culture in depth. All the chapters have been written by leading experts in this field, making the Handbook the essential reference source for the professional microbiologist.
Автор: Goldstein, Walter E. Название: Pharmaceutical Accumulation in the Environment ISBN: 146651745X ISBN-13(EAN): 9781466517455 Издательство: Taylor&Francis Рейтинг: Цена: 24499.00 р. Наличие на складе: Нет в наличии.
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