Fundamentals of International Pharmaceutical and Biologics Regulations
Author: Zeeshaan Arshad
Publisher:
Published: 2017
Total Pages: 252
ISBN-13: 9780997769739
DOWNLOAD EBOOK →Author: Zeeshaan Arshad
Publisher:
Published: 2017
Total Pages: 252
ISBN-13: 9780997769739
DOWNLOAD EBOOK →Author: Gloria Hall
Publisher:
Published: 2018-09-04
Total Pages:
ISBN-13: 9781947493216
DOWNLOAD EBOOK →Author: Regulatory Affairs Professionals Society
Publisher:
Published: 2023-05
Total Pages: 0
ISBN-13: 9781947493865
DOWNLOAD EBOOK →Author:
Publisher:
Published: 2014-05-23
Total Pages:
ISBN-13: 9780989802864
DOWNLOAD EBOOK →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:
Published: 2020-07-29
Total Pages:
ISBN-13: 9781947493513
DOWNLOAD EBOOK →Author: Rebecca Sheets
Publisher: Academic Press
Published: 2017-12-13
Total Pages: 450
ISBN-13: 0128094435
DOWNLOAD EBOOK →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: Gloria Hall
Publisher:
Published: 2018-04-23
Total Pages:
ISBN-13: 9781947493124
DOWNLOAD EBOOK →Author: Pamela A. Jones
Publisher:
Published: 2019
Total Pages:
ISBN-13: 9781947493315
DOWNLOAD EBOOK →Author: Gloria Hall
Publisher:
Published: 2021-07-23
Total Pages:
ISBN-13: 9781947493698
DOWNLOAD EBOOK →Author:
Publisher:
Published: 2014-05-23
Total Pages:
ISBN-13: 9780989802888
DOWNLOAD EBOOK →Compilation of pharmaceutical and biologics chapters from Fundamentals of EU Regulatory Affairs Sixth Edition, Fundamentals of Canadian Regulatory Affairs Fourth Edition and Fundamentals of Japanese Regulatory Affairs First Edition.