About this book
This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice.
It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations.
The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products.
This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.
Editors and affiliations
- DOI https://doi.org/10.1007/978-3-030-35626-2
- Copyright Information Springer Nature Switzerland AG 2020
- Publisher Name Springer, Cham
- eBook Packages Biomedical and Life Sciences
- Print ISBN 978-3-030-35625-5
- Online ISBN 978-3-030-35626-2
- Series Print ISSN 2509-6125
- Series Online ISSN 2509-6133
- Buy this book on publisher's site