Author: Gloria Hall
Publisher:
ISBN: 9781947493698
Category :
Languages : en
Pages :
Book Description
Fundamentals of Pharmaceutical and Biologics Regulations: a Global Perspective
Author: Regulatory Affairs Professionals Society
Publisher:
ISBN: 9781947493865
Category :
Languages : en
Pages : 0
Book Description
Publisher:
ISBN: 9781947493865
Category :
Languages : en
Pages : 0
Book Description
Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition
Author: Gloria Hall
Publisher:
ISBN: 9781947493513
Category : Biologicals
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781947493513
Category : Biologicals
Languages : en
Pages :
Book Description
Fundamentals of Pharmaceutical and Biologics Regulations, Fourth Edition
Author: Gloria Hall
Publisher:
ISBN: 9781947493698
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781947493698
Category :
Languages : en
Pages :
Book Description
Fundamentals of Pharmaceutical and Biologics Regulations
Author: Pamela A. Jones
Publisher:
ISBN: 9781947493315
Category : Biologicals
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781947493315
Category : Biologicals
Languages : en
Pages :
Book Description
Fundamentals of International Pharmaceutical and Biologics Regulations
Author: Zeeshaan Arshad
Publisher:
ISBN: 9780997769739
Category : Biologicals
Languages : en
Pages : 252
Book Description
Publisher:
ISBN: 9780997769739
Category : Biologicals
Languages : en
Pages : 252
Book Description
Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition
Author: Gloria Hall
Publisher:
ISBN: 9781947493414
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781947493414
Category :
Languages : en
Pages :
Book Description
Fundamentals of International Pharmaceutical and Biologics Regulations
Author: Gloria Hall
Publisher:
ISBN: 9781947493216
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781947493216
Category :
Languages : en
Pages :
Book Description
Fundamentals of EU Pharmaceutical and Biologics Regulations
Author: Gloria Hall
Publisher:
ISBN: 9781947493124
Category :
Languages : en
Pages :
Book Description
Publisher:
ISBN: 9781947493124
Category :
Languages : en
Pages :
Book Description
Fundamentals of US Pharmaceutical and Biologics Regulations
Author: Syed Rizwanuddin Ahmad
Publisher:
ISBN: 9781947493018
Category :
Languages : en
Pages :
Book Description
Laws and regulations governing pharmaceutical and biologics products manufacture and marketing in the US.
Publisher:
ISBN: 9781947493018
Category :
Languages : en
Pages :
Book Description
Laws and regulations governing pharmaceutical and biologics products manufacture and marketing in the US.
Fundamentals of Biologicals Regulation
Author: Rebecca Sheets
Publisher: Academic Press
ISBN: 0128094435
Category : Medical
Languages : en
Pages : 452
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
Publisher: Academic Press
ISBN: 0128094435
Category : Medical
Languages : en
Pages : 452
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