The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
Fundamentals of US Regulatory Affairs, Eighth Edition
Reference book of laws and regulations governing healthcare product manufacture and marketing in the EU.
Reference book of regulations and laws covering healthcare product manufacture and marketing in the US.
Fundamentals of EU Regulatory Affairs,Sixth Edition
Fundamentals of EU Regulatory Affairs
Fundamentals of EU Regulatory Affairs, Fourth Edition
Fundamentals of Pharmaceutical and Biologics Regulations, Third Edition
Fundamentals of US Regulatory Affairs
A valuable resource for instructors in the classroom and regulated community such as law, medicine, pharmacy, food, nursing and biotechnology. The manual addresses the points discussed in the text in...
Fundamentals of US Regulatory Affairs