Pharmaceutical Drug Product Development and Process Optimization, Beg, Sarwar
Автор: Watson David G. Название: Pharmaceutical Analysis. 5 ed ISBN: 0702078077 ISBN-13(EAN): 9780702078071 Издательство: Elsevier Science Рейтинг: Цена: 35370.00 T Наличие на складе: Есть Описание: Pharmaceutical analysis determines the purity, concentration, active compounds, shelf life, rate of absorption in the body, identity, stability, rate of release etc. of a drug. Testing a pharmaceutical product involves a variety of analyses, and the analytical processes described in this book are used in industries as diverse as food, beverages, cosmetics, detergents, metals, paints, water, agrochemicals, biotechnological products and pharmaceuticals. The mathematics involved is notoriously difficult, but this much-praised textbook, now revised and updated for its fifth edition, guides a student through the complexities with clear writing and the author's expertise from many years' teaching pharmacy students. Two new chapters have been added to the new edition covering methods used in the quality control of biotechnologically produced drugs, and electrochemical biosensors. There is continuous learning reinforcement throughout the book by way of worked calculation examples and self-assessment test questions. Worked calculation examples Self-assessment Additional problems (self tests) Practical boxes Key points boxes Two new chapters: Chapter 16 Methods used in the quality control of biotechnologically produced drugs Chapter 17 Electrochemical biosensors
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: Katja Strohfeldt-Venables Название: Essentials of Inorganic Chemistry: For Students of Pharmacy, Pharmaceutical Sciences and Medicinal Chemistry.- Wiley, 2015 ISBN: 0470665580 ISBN-13(EAN): 9780470665589 Издательство: Wiley Рейтинг: Цена: 49580.00 T Наличие на складе: Поставка под заказ. Описание: A comprehensive introduction to inorganic chemistry and, specifically, the science of metal-based drugs, Essentials of Inorganic Chemistry describes the basics of inorganic chemistry, including organometallic chemistry and radiochemistry, from a pharmaceutical perspective.
Автор: Watson, David G. (Senior Lecturer in Pharmaceutical Sciences, Strathclyde Institute of Pharmaceutical and Biomedical Sciences, University of Strathcly Название: Pharmaceutical and Medicinal Chemistry. Elsevier,2011 ISBN: 9780443072321\Давид Уотсон:Фармацевтическая и лекарственная химия, Элзивир,2011 ISBN: 0443072329 ISBN-13(EAN): 9780443072321 Издательство: Elsevier Science Рейтинг: Цена: 49390.00 T Наличие на складе: Поставка под заказ. 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.
Автор: Lal, H. Название: Essentials of Pharmaceutical Biochemistry: CBS Publishers & Distributrors, 2019.- ISBN: 9789386478580 /Основы фармацевтической биохимии, включая практические упражнения ISBN: 9386478587 ISBN-13(EAN): 9789386478580 Издательство: CBS India Рейтинг: Цена: 31350.00 T Наличие на складе: Нет в наличии. 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.
Автор: Yuichi Sugiyama; Bente Steffansen Название: Transporters in Drug Development ISBN: 1461482283 ISBN-13(EAN): 9781461482284 Издательство: Springer Рейтинг: Цена: 156720.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Transporters in Drug Development examines how membrane transporters can be dealt with in academic-industrial drug discovery and pharmaceutical development as well as from a regulatory perspective.
Автор: Yuichi Sugiyama; Bente Steffansen Название: Transporters in Drug Development ISBN: 1493952064 ISBN-13(EAN): 9781493952069 Издательство: Springer Рейтинг: Цена: 130590.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Transporters in Drug Development is a corner stone in a high profile book series on advances in pharmaceutical sciences initiated by AAPS, Springer and Professor Daan Crommelin as series Editor. Transporters in Drug Development: Discovery, Optimization, Clinical Study and Regulation list chapters written by leading researchers in the transporter field from academia, pharmaceutical industry and medicines agencies. The book encompasses examples and advises on how membrane transporters can be dealt with in academic industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. Methods and examples of in vitro characterization of single transporters in intestine, liver and kidney are described as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are discussed as well as the perspectives of applying targeted proteomics and mechanistic modelling in this process.
Автор: Parag Kolhe; Mrinal Shah; Nitin Rathore Название: Sterile Product Development ISBN: 1461479770 ISBN-13(EAN): 9781461479772 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book addresses key concepts and applications in sterile product development. Throughout, it illustrates key concepts relevant to the successful development of sterile products with the help of case studies.
The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management.
Автор: Fytopoulos Antonios, Ramachandran Rohit, Pardalos Panos M. Название: Optimization of Pharmaceutical Processes ISBN: 3030909239 ISBN-13(EAN): 9783030909239 Издательство: Springer Рейтинг: Цена: 79190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Optimization of Pharmaceutical Processes presents contributions from leading authorities in the fields of optimization and pharmaceutical manufacturing. Formulated within structured frameworks, practical examples and applications are given as guidance to apply optimization techniques to most aspects of pharmaceutical processes from design, to lab and pilot scale, and finally to manufacturing. The increasing demand for better quality, higher yield, more efficient-optimized and green pharmaceutical processes, indicates that optimal conditions for production must be applied to achieve simplicity, lower costs and superior yield. The application of such methods in the pharmaceutical industry is not trivial. Quality of the final product is of major importance to human health and the need for deep knowledge of the process parameters and the optimization of the processes are imperative. The volume, which includes new methods as well as review contributions will benefit a wide readership including engineers in pharmaceuticals, chemical, biological, to name just a few.
Автор: Michael A. Repka; Nigel Langley; James DiNunzio Название: Melt Extrusion ISBN: 1461484316 ISBN-13(EAN): 9781461484318 Издательство: Springer Рейтинг: Цена: 174150.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book describes hot melt extrusion for pharmaceutical applications, focusing on the materials used for the preparation of solid dispersions and the fundamentals for preparing such systems using extrusion technology.
The definitive textbook on the chemical analysis of pharmaceutical drugs - fully revised and updated
Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals.
This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension.
Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics
Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject
Examines various analytical techniques commonly used in pharmaceutical laboratories
Provides practice problems, up-to-date practical examples and detailed illustrations
Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines
Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.
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