Drug Biotechnology Regulation
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Drug Biotechnology Regulation
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Author : Y. Chiu
language : en
Publisher: CRC Press
Release Date : 1991-01-07
Drug Biotechnology Regulation written by Y. Chiu and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1991-01-07 with Medical categories.
An examination of the relation between biodrug development and governmental regulation, focusing on the present state of collective knowledge of biotechnological practitioners, including the identification of the scientific basis on regulatory requirements in the field, as well as ways in which the
Reinventing The Regulation Of Drugs Made From Biotechnology
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Author : Bill Clinton
language : en
Publisher:
Release Date : 1995
Reinventing The Regulation Of Drugs Made From Biotechnology written by Bill Clinton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Biotechnology categories.
Pharmaceutical Biotechnology
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Author : Oliver Kayser
language : en
Publisher: John Wiley & Sons
Release Date : 2012-05-21
Pharmaceutical Biotechnology written by Oliver Kayser and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-21 with Science categories.
This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
Quality By Design For Biopharmaceuticals
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Author : Anurag S. Rathore
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Quality By Design For Biopharmaceuticals written by Anurag S. Rathore and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Science categories.
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Medical Product Regulatory Affairs
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Author : John J. Tobin
language : en
Publisher: John Wiley & Sons
Release Date : 2011-08-24
Medical Product Regulatory Affairs written by John J. Tobin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-24 with Science categories.
Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/Manufacturing Practices. Everything pharmacologists, bioengineers, pharma engineers, students in pharmacy and those working in the pharmaceutical industry need to know about medical regulatory affairs.
Fundamentals Of Biologicals Regulation
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Author : Rebecca Sheets
language : en
Publisher: Academic Press
Release Date : 2017-12-13
Fundamentals Of Biologicals Regulation written by Rebecca Sheets and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-12-13 with Medical categories.
Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products
The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals
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Author : John Geigert
language : en
Publisher: Springer
Release Date : 2019-05-08
The Challenge Of Cmc Regulatory Compliance For Biopharmaceuticals written by John Geigert and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-05-08 with Medical categories.
Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.
Handbook Of Biogeneric Therapeutic Proteins
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2002-08-15
Handbook Of Biogeneric Therapeutic Proteins written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2002-08-15 with Medical categories.
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality. Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues. The book provides complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins and how to prepare detailed regulatory and manufacturing plans and policies. The author includes information on establishing a manufacturing system, securing regulatory approval, and setting up facilities to manufacture raw materials and prepare finished products. He also supplies details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products. In brief, the book supplies everything a manufacturer would need to plan the development of biogeneric products and complete the process of regulatory filing. Waiting for the FDA to issue guidelines is a mistake. The scramble to catch up could leave your company way behind in the game. Your organization needs to begin developing and characterizing genetically modified cells now and to complete initial GMP production runs through a CRO to get ready for the newer testing the FDA might impose. Packed with tables and figures that provide speedy access to precise, timely data, including full formulation details on all FDA approved biological product, this book contains a broad range of resource materials about suppliers, manufacturers, and testing facilities. These features combined with the author's hands-on, practical approach give you the edge you need.
Targeted Regulatory Writing Techniques Clinical Documents For Drugs And Biologics
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Author : Linda Fossati Wood
language : en
Publisher: Springer Science & Business Media
Release Date : 2009-01-05
Targeted Regulatory Writing Techniques Clinical Documents For Drugs And Biologics written by Linda Fossati Wood and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-01-05 with Medical categories.
This book describes the authors’ standard or ‘best’ practices used in writing regul- ed clinical documents for the drug and biologics industry. The fundamental premise of this book is that the end (documents submitted to a health authority) is dep- dent on the beginning (the planning and strategy that go into organizing written documentation). Each regulatory document inherently exists within a constellation of related documents. This book attempts to show the relationships between and among these documents and suggests strategies for organizing and writing these documents to maximize ef?ciency while developing clear and concise text. At all times, and irrespective of applicable laws and guidelines, good communication skills and a sense of balance are essential to adequately, accurately, and clearly describe a product’s characteristics. At no time should the reader perceive these suggestions to be the only viable solution to writing regulatory documents nor should the reader expect that these suggestions guarantee product success. The audience for this book is the novice medical writer, or those who would like to explore or enhance regulatory-writing skills. We assume the reader will have a basic understanding of written communication, but little experience in applying this skill to the task of regulatory writing. Extensive knowledge of science, clinical me- cine, mathematics, or regulatory affairs law is not required to use the best practices described in this book.
Reinventing Regulation Of Drugs Made From Biotechnology
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Author : Bill Clinton
language : en
Publisher:
Release Date : 1995
Reinventing Regulation Of Drugs Made From Biotechnology written by Bill Clinton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1995 with Biotechnology categories.