Handbook of Analytical Validation, Swartz, Michael E.
Автор: Riley, Christopher M. Название: Riley - Spec of Drug Substances and Products, 2e ISBN: 0081028245 ISBN-13(EAN): 9780081028247 Издательство: Elsevier Science Рейтинг: Цена: 28633.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered-or not substantially covered-in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products.
The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.
Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
Written by subject-matter experts involved in the development and application of the guidelines
Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction
Автор: Huber, Ludwig Название: Validation and Qualification in Analytical Laboratories ISBN: 084938267X ISBN-13(EAN): 9780849382673 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Specification of drug substances and products ISBN: 0080983502 ISBN-13(EAN): 9780080983509 Издательство: Elsevier Science Рейтинг: Цена: 13980.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Huber, Ludwig Название: Validation of Computerized Analytical Systems ISBN: 036740172X ISBN-13(EAN): 9780367401726 Издательство: Taylor&Francis Рейтинг: Цена: 6736.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.
International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout the book assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.
While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use, and how to produce the appropriate documentation. This book's user-friendly diagrams and other clear graphics illustrate key ideas throughout each protocol, offering a bird's-eye view of what is coming next-and they quickly guide you through the equipment validation. The author provides a thorough understanding of how to prepare, test, and complete equipment qualification protocols. He also explains how to perform qualification testing and whether to test the equipment for a worst case scenario.
No other book deals exclusively with the key issues of equipment qualification and process validation for pharmaceutical process equipment-and provides instructions on how to achieve it. With pragmatic approach, this book includes 38 useful protocol templates, already completed, that provide instant answers to most protocol writing and testing questions. These templates cover specific equipment types, such, and provide accurate, industry acceptable equipment qualification protocols. Step-by-step, they show how to qualify each piece of equipment, and they provide a check for readers own protocols.
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.
Название: Herbal Medicines ISBN: 1439837686 ISBN-13(EAN): 9781439837689 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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: Bernd W. Wenclawiak; Michael Koch; Evsevios Hadjic Название: Quality Assurance in Analytical Chemistry ISBN: 3642448518 ISBN-13(EAN): 9783642448515 Издательство: Springer Рейтинг: Цена: 9141.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In this revised and enlarged textbook, the authors provide an in-depth but easy to understand coverage of quality assurance for chemical measurements. In particular the chapters on measurement uncertainty, calibration and validation are practically all new.
Автор: Uchiyama Название: Analytical Ultracentrifugation ISBN: 4431567453 ISBN-13(EAN): 9784431567455 Издательство: Springer Рейтинг: Цена: 20962.00 р. Наличие на складе: Поставка под заказ.
Описание: This book introduces analytical ultracentrifugation (AUC) as a whole, covering essential theoretical and practical aspects as well as its applications in both biological and non-biological systems. Comprehensive characterizations of macromolecules in a solution are now routinely required not only for understanding the solution system but also for producing a solution with better properties. Analytical ultracentrifugation is one of most powerful and reliable techniques for studying the biophysical behavior of solutes in solution. In the last few years, there have been steady advances made in hardware, software, and applications for AUC. This book provides chapters that cover everything essential for beginners to the most advanced users and also offer updated knowledge of the field on advances in hardware, software, and applications. Recent development of hardware described in this book covers new detection systems that give added dimensions to AUC. Examples of data analysis with essential theoretical explanations for advanced and recently updated software are also introduced. Besides AUC of biological systems including membrane proteins and biopharmaceuticals, AUC applications for non-biological questions are included. AUC studies under non-ideal conditions such as highly concentrated solutions and solutions with high salt concentration are also included. The contributors to this book are leading researchers in the fields of solution biophysics and physical chemistry who extensively employ AUC analysis for their research. From this published work, one can gain new and comprehensive knowledge of recent AUC analysis.
Автор: Chow, Shein-Chung Название: Statistical Design and Analysis in Pharmaceutical Science ISBN: 0824793366 ISBN-13(EAN): 9780824793364 Издательство: Taylor&Francis Рейтинг: Цена: 22202.00 р. Наличие на складе: Поставка под заказ.
Автор: Nash, Robert A. Название: Pharmaceutical Process Validation ISBN: 0824708385 ISBN-13(EAN): 9780824708382 Издательство: Taylor&Francis Рейтинг: Цена: 33686.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
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