How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control.
With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing.
Discusses the development of strategy blueprints in the design of continuous processes
Shows how to create process flowsheet models from individual unit operation models
Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases
Covers the evolving regulatory expectations for continuous manufacturing
Provides readers with ways to more effectively navigate these expectations
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.)
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.
Описание: This book includes all of the theory as well as the practical side of pharmaceutical biochemistry, presented in a simple, yet comprehensive, way. It includes chapters on topics such as biomolecules, biogeneratics, energy rich compounds, biological oxidation, the catalytic role of enzymes, the importance of enzyme inhibitors in the design of new drugs, and therapeutic and diagnostic applications of enzymes.
Описание: Specifically geared to personnel in the pharmaceutical and biotechnology industries, this book describes the basics and challenges of oral bioavailability one of the most significant hurdles in drug discovery and development.
Описание: This core reference explains current strategies for immunotoxicology pharmaceutical safety assessments, which can reduce drug candidate attrition and streamline the development process.
Автор: Guy Wingate, Glaxo Smith Kline, Durham, UK Название: Pharmaceutical Computer Systems Validation ISBN: 1420088947 ISBN-13(EAN): 9781420088946 Издательство: Taylor&Francis Рейтинг: Цена: 29093.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Pharmaceutical Computer Systems Validation
Автор: Hedaya Mohsen A. Название: Basic Pharmacokinetics, Second Edition ISBN: 1439850739 ISBN-13(EAN): 9781439850732 Издательство: Taylor&Francis Рейтинг: Цена: 15310.00 р. Наличие на складе: Поставка под заказ.
Описание: Knowledge of pharmacokinetics is critical to understanding the absorption, distribution, metabolism, and excretion of drugs. Accessible to a wide variety of readers, this volume demonstrates the quantitative pharmacokinetic relations and the interplay between pharmacokinetic parameters. Accompanying the book are downloadable resources with self-
Описание: In a classical alphabetical format, this two-volume reference covers more than 1000 painstakingly screened natural product structures. For each compound or compound class, a basic chemical characterization is given, followed by a description of the biological source and a discussion of their pharmaceutical potential as lead molecules for new drugs.
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the
USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.
Автор: Howard Fillit, Jefferson Kinney, Jeffrey Cummings Название: Alzheimer`s Disease Drug Development: Research and Development Ecosystem ISBN: 1108838669 ISBN-13(EAN): 9781108838665 Издательство: Cambridge Academ Рейтинг: Цена: 16474.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Provides a definitive overview of the complex ecosystem facilitating Alzheimer`s Disease drug research and development. Demonstrates a drug`s journey from in the lab, clinical trial testing, regulatory review, and marketing by pharmaceutical companies. Details the use of artificial intelligence, clinical trial management, and financing models.
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