Continuous pharmaceutical processing and process analytical technology, Daems, Ies
Автор: Watson David G. Название: Pharmaceutical Analysis. 5 ed ISBN: 0702078077 ISBN-13(EAN): 9780702078071 Издательство: Elsevier Science Рейтинг: Цена: 5305.00 р. 7578.00-30% Наличие на складе: Есть (5 шт.) 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
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.
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: Parikh, Dilip Название: How to Optimize Fluid Bed Processing Technology ISBN: 0128047275 ISBN-13(EAN): 9780128047279 Издательство: Elsevier Science Рейтинг: Цена: 8588.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference.
This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation.
Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation.
Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering
Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques
Offers troubleshooting tips and practical advice for scientists working with this technique
Автор: Girish Kumar Gupta, Vinod Kumar Название: Chemical Drug Design ISBN: 3110374498 ISBN-13(EAN): 9783110374490 Издательство: Walter de Gruyter Цена: 18586.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Chemical Drug Design provides a compact overview on recent advances in this rapidly developing field. With contributions on in silico drug design, natural product based compounds, as well as on ligand- and structure-based approaches, the authors present innovative methods and techniques for identifying and synthetically designing novel drugs.
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: Nagy Zoltan K., El Hagrasy Arwa, Litster Jim Название: Continuous Pharmaceutical Processing ISBN: 3030415236 ISBN-13(EAN): 9783030415235 Издательство: Springer Рейтинг: Цена: 16769.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Basic Principles of Continuous Manufacturing.- Continuous Reactors for Pharmaceutical Manufacturing.- Understanding Residence Time, RTD, and Impact of Surge Vessels.- Practical Considerations for Continuous Drug Substance Manufacturing.- Continuous Crystallization: Equipment and Operation.- Continuous Feeding-Blending in Pharmaceutical Continuous Manufacturing.- Recent Progress in Roll Compaction Process Development for Pharmaceutical Solid Dosage Form Manufacture.- Continuous wet granulation processes.- Fluidized Bed Drying.- Statistical Methods in Quality by Design and Process Analytical Technologies for continuous processes to enable real-time release.- Active Process Control in Pharmaceutical Continuous Manufacturing-The Quality by Control (QbC) Paradigm.- Real-time Optimization in Pharmaceutical Manufacturing.- Safety Guidelines for Continuous Chemistry Experimental Work in the Laboratory.- Evaluating the Busieness/Supply Chain Benefits of Continuous Processing in Pharmaceuticals.- Regulatory Considerations for Continuous Manufacturing.
Автор: Nagy Zoltan K., El Hagrasy Arwa, Litster Jim Название: Continuous Pharmaceutical Processing ISBN: 3030415260 ISBN-13(EAN): 9783030415266 Издательство: Springer Цена: 16769.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges.
Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.
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.
Автор: McCormick, Kate Jr, D. Wylie McVay Название: Pharmaceutical Process Design and Management ISBN: 1138255505 ISBN-13(EAN): 9781138255500 Издательство: Taylor&Francis Рейтинг: Цена: 7961.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: A quality product or service is the successful and profitable outcome of organising resources, as judged by the final customer. Every business unit needs processes in order to do this effectively; and all processes must be documented so that achievements can be measured and future improvements planned and implemented. Pharmaceutical Process Design and Management takes a step-wise approach to process management. It presents the various elements comprising a process (man, machine, materials, method and environment); it looks at quality control and quality assurance, tools for quality improvements and ways of structuring a process into discrete, fully accountable elements; it proposes that for processes to run successfully, all operators must be the initial problem-solvers; finally, it illustrates how, with the right tools, every problem can be broken down into solvable elements. Learn how to deploy a science and risk-based approach to pharmaceutical manufacturing, by taking a fundamental approach to process design and management and, as a consequence, keep your customers satisfied and your profits healthy.
Автор: Renata Jastrzab, Bartosz Tylkowski Название: New-Generation Bioinorganic Complexes ISBN: 3110348802 ISBN-13(EAN): 9783110348804 Издательство: Walter de Gruyter Цена: 24165.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Bio-Inorganic compounds are successfully applied as therapeutic agents since decades. Thus, scientist designed new metal complexes bearing biomolecules as ligands, investigating their potential as bioactive and therapeutic agents. This book presents a comprehensive overview on materials design, substance classes and their characterization. This book is compiled for scientists interested in medical application of bioinspired materials.
Автор: Carol Jessica Название: Pharmaceutical Applications of Analytical Chemistry ISBN: 1682861279 ISBN-13(EAN): 9781682861271 Издательство: Неизвестно Цена: 23333.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Analytical chemistry involves the identification and separation of chemical elements in both artificial and natural substances. This discipline has found its application in multiple fields like forensics, environmental and clinical analysis, etc. This book focuses on the experimental and analytical tools & methods utilized in the development and production of pharmaceutics. The researches included in this book provide new insights into the modern theories and applications of this field. It will serve as a valuable source of reference to students, academicians and professionals engaged in this area.
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