Fundamentals of International Pharmaceutical and Biologics Regulations PDF Download
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Author: Zeeshaan Arshad
Publisher:
ISBN: 9780997769739
Category : Biologicals
Languages : en
Pages : 252
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Book Description
Author: Zeeshaan Arshad
Publisher:
ISBN: 9780997769739
Category : Biologicals
Languages : en
Pages : 252
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493216
Category :
Languages : en
Pages :
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Book Description
Author: Regulatory Affairs Professionals Society
Publisher:
ISBN: 9781947493865
Category :
Languages : en
Pages : 0
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493513
Category : Biologicals
Languages : en
Pages :
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Book Description
Author:
Publisher:
ISBN: 9780989802864
Category :
Languages : en
Pages :
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Book Description
Compilation of the pharmaceutical and biologics chapters from Fundamentals of US Regulatory Affairs Eighth Edition and Fundamentals of International Regulatory Affairs Second Edition,
Author: Gloria Hall
Publisher:
ISBN: 9781947493124
Category :
Languages : en
Pages :
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Book Description
Author: Gloria Hall
Publisher:
ISBN: 9781947493698
Category :
Languages : en
Pages :
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Book Description
Author: Rebecca Sheets
Publisher: Academic Press
ISBN: 0128094435
Category : Medical
Languages : en
Pages : 450
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Book Description
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
Author: Pamela A. Jones
Publisher:
ISBN: 9781947493315
Category : Biologicals
Languages : en
Pages :
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Book Description
Author: Javed Ali
Publisher: Academic Press
ISBN: 0128222239
Category : Medical
Languages : en
Pages : 287
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Book Description
Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
