Regulatory Affairs in the Pharmaceutical Industry, Ali Javed, Baboota Sanjula
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
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: Watson, David G. Название: Pharmaceutical Analysis International Edition 5 : Elsevier Science.- ISBN 9780702078088 СОЕДИНЕННОЕ КОРОЛЕВСТВО ISBN: 0702078085 ISBN-13(EAN): 9780702078088 Издательство: Elsevier Science Рейтинг: Цена: 31430.00 T Наличие на складе: Поставка под заказ. 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.
Автор: Gutka Hiten J., Yang Harry, Kakar Shefali Название: Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development ISBN: 3319996797 ISBN-13(EAN): 9783319996790 Издательство: Springer Рейтинг: Цена: 158380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Название: Drug Discovery and Development, Third Edition ISBN: 1138080268 ISBN-13(EAN): 9781138080263 Издательство: Taylor&Francis Рейтинг: Цена: 224570.00 T Наличие на складе: Нет в наличии. Описание: The third edition of The Process of New Drug Discovery and Development presents a practical methodology and up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace.
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.
Автор: Trupti Patil Dongare, Dongare Название: Gmp in pharmaceutical industry ISBN: 9388305140 ISBN-13(EAN): 9789388305143 Издательство: Неизвестно Рейтинг: Цена: 81790.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This handbook has been written for the students of pharmacy and pharmaceutical industry. It gives pocket guide of good manufacturing practices in pharmaceutical industry. The purpose of this handbook is to provide easily accessible knowledge about the pharmaceutical industry and to assist individuals to know about pharmaceutical world
Автор: Papiya Bigonia Название: Drug Regulatory Affairs ISBN: 9388902963 ISBN-13(EAN): 9789388902960 Издательство: CBS India Рейтинг: Цена: 34490.00 T Наличие на складе: Нет в наличии. Описание: Drug Regulatory Affairs is a compilation of fundamental concepts pertaining to pharmaceutical drug regulation. Governments protect public health by strictly controlling the safety and efficacy of human medicine, veterinary medicines, medical devices, cosmetics and complementary medicines. Companies responsible for the discovery, testing, manufacture and marketing of these products must ensure sale of safe and effective products. Drug Regulatory Affairs refers to fulfilment of all aspects of drug regulations within the pharmaceutical companies from development process to finished product marketing.
The book provides a sound basis on understanding of international drug regulatory guidelines controlling the quality, safety and purity of marketed drugs. The content of this book covers the syllabus of pharmacy undergraduate and postgraduate course content of drug regulatory affairs. The text focuses on delivering updated and reviewed up-to-date information on current global regulatory guidelines. The book contains information that is substantial to a comprehensive understanding of regulatory affairs and the practice in pharmaceutical industry.
Автор: Patravale, Vandana B. Название: Pharmaceutical Product Development ISBN: 1032238011 ISBN-13(EAN): 9781032238012 Издательство: Taylor&Francis Рейтинг: Цена: 48990.00 T Наличие на складе: Есть у поставщика Поставка под заказ.
Название: Good Manufacturing Practices Pharma ISBN: 1498732062 ISBN-13(EAN): 9781498732062 Издательство: Taylor&Francis Рейтинг: Цена: 178640.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.
Key Features:
Presents insight into the world of pharmaceutical quality systems
Analyzes regulatory trends and expectations
Includes approaches and practices used in the industry to comply with regulatory requirements
Discusses recent worldwide supply chain issues
Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry
Автор: Reem K. Al-Essa; Mohammed Al-Rubaie; Stuart Walker Название: Pharmaceutical Regulatory Environment ISBN: 3319175890 ISBN-13(EAN): 9783319175898 Издательство: Springer Рейтинг: Цена: 79190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients' access to new medicines.
The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region.
Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
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