Overview
- Provides step-by-step procedures, from idea to commercially viable biomedical product
- Guides readers through the good practice principles and regulations
- Highlights ethical aspects
- Offers insights into pre-clinical and clinical study design
- Serves as an indispensable guide for scientists and professionals in biomedical product development
Part of the book series: Learning Materials in Biosciences (LMB)
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Table of contents (14 chapters)
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Front Matter
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Back Matter
Keywords
- Bench to Bedside
- Principles of good practice
- GLP
- GMP
- GCP
- Safety standards
- Bioethics
- Ethical codes
- Quality management
- Biomedical products
- Product development
- Design of experimental studies
- Study design
- Manufacturing processes
- Clinical studies
- Clinical trial
- Regulatory subsystems
- Regenerative therapies
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
About the editors
Dr. Moloud Payab obtained her B.Sc. and M.S. in Nutrition Sciences from Tehran Islamic Azad University in 2007 and Tehran University of Medical Sciences in 2011, respectively. She then completed her Ph.D. at the Obesity and Eating Habits Research Center, at the Endocrinology and Metabolism Clinical Sciences Institute (EMRI), which is affiliated to Tehran University of Medical Sciences. She has worked as a researcher at EMRI since 2012. To date, Dr. Payab’s research has mostly been in the field of clinical and population studies from an endocrinology perspective, including but not limited to obesity. Further, she has been actively involved in designing, planning, implementing and monitoring several basic and clinical research projects. Her particular interest is cell therapy in the field of obesity using various cell-based products, and she closely collaborates with the Cell Therapy and Regenerative Medicine Research Center at EMRI.
Dr. Parisa Goodarzi obtained her B.Sc. in Nursing at Tehran University of Medical Sciences Iran in 1996. Then, she completed her M.S. in Geriatric Nursing at Iran University of Medical Sciences, Tehran, Iran in 2016. Since 2008, Parisa Goodarzi has worked as a researcher at Tehran University of Medical Sciences. She has extensive experience in the implementation of quality management systems (QMS) in the field of cell and tissue-based products and product development pathways. She is also the author of more than 50 articles that have been published in scientific journals, books and conference proceedings.
Bibliographic Information
Book Title: Biomedical Product Development: Bench to Bedside
Editors: Babak Arjmand, Moloud Payab, Parisa Goodarzi
Series Title: Learning Materials in Biosciences
DOI: https://doi.org/10.1007/978-3-030-35626-2
Publisher: Springer Cham
eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)
Copyright Information: Springer Nature Switzerland AG 2020
Softcover ISBN: 978-3-030-35625-5Published: 06 February 2020
eBook ISBN: 978-3-030-35626-2Published: 05 February 2020
Series ISSN: 2509-6125
Series E-ISSN: 2509-6133
Edition Number: 1
Number of Pages: XIV, 157
Number of Illustrations: 16 illustrations in colour
Topics: Biomedical Engineering/Biotechnology, Regenerative Medicine/Tissue Engineering, Medicine/Public Health, general, Biomedical Engineering and Bioengineering, Pharmaceutical Sciences/Technology, Biotechnology