Fundamentals of Biologicals Regulation PDF
By:Rebecca Sheets
Published on 2017-12-13 by Academic Press
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
This Book was ranked at 18 by Google Books for keyword Fundamentals.
Book ID of Fundamentals of Biologicals Regulation's Books is rRd2DQAAQBAJ, Book which was written byRebecca Sheetshave ETAG "oDubWpx1faQ"
Book which was published by Academic Press since 2017-12-13 have ISBNs, ISBN 13 Code is 9780128094433 and ISBN 10 Code is 0128094435
Reading Mode in Text Status is true and Reading Mode in Image Status is true
Book which have "450 Pages" is Printed at BOOK under CategoryMedical
Book was written in en
eBook Version Availability Status at PDF is true and in ePub is true
Book Preview
Download Fundamentals of Biologicals Regulation PDF Free
Download Fundamentals of Biologicals Regulation Books Free
Download Fundamentals of Biologicals Regulation Free
Download Fundamentals of Biologicals Regulation PDF
Download Fundamentals of Biologicals Regulation Books
Tidak ada komentar:
Posting Komentar