Advertisement

Biomedical Product Development: Bench to Bedside

  • Babak Arjmand
  • Moloud Payab
  • Parisa Goodarzi
Textbook
  • 1.1k Downloads

Part of the Learning Materials in Biosciences book series (LMB)

Table of contents

  1. Front Matter
    Pages I-XIV
  2. Babak Arjmand, Moloud Payab, Parisa Goodarzi
    Pages 1-3
  3. Babak Arjmand, Motahareh Sheikh-Hosseini, Fakher Rahim, Hossein Adibi, Alireza Baradaran-Rafii, Bagher Larijani
    Pages 5-15
  4. Motahareh Sheikh-Hosseini, Parisa Goodarzi, Hamid Reza Aghayan, Kambiz Gilany, Firoozeh Ghaderi, Mahdi Gholami et al.
    Pages 17-35
  5. Bagher Larijani, Akram Tayanloo-Beik, Moloud Payab, Mahdi Gholami, Motahareh Sheikh-Hosseini, Mehran Nematizadeh
    Pages 37-47
  6. Mehran Nematizadeh, Moloud Payab, Mahdi Gholami, Babak Arjmand, Bagher Larijani, Akram Tayanloo-Beik
    Pages 49-60
  7. Masoumeh Sarvari, Sepideh Alavi-Moghadam, Bagher Larijani, Ilia Rezazadeh, Babak Arjmand
    Pages 61-68
  8. Sepideh Alavi-Moghadam, Masoumeh Sarvari, Parisa Goodarzi, Hamid Reza Aghayan
    Pages 69-79
  9. Fereshteh Mohamadi-Jahani, Mina Abedi, Maryam Arabi, Akram Tayanloo-Beik, Bagher Larijani
    Pages 81-88
  10. Maryam Arabi, Fereshteh Mohamadi-Jahani, Sepideh Alavi-Moghadam, Mina Abedi
    Pages 89-97
  11. Najmeh Foroughi-Heravani, Mahdieh Hadavandkhani, Babak Arjmand, Bagher Larijani, Alireza Baradaran-Rafii, Ensieh Nasli-Esfahani et al.
    Pages 99-106
  12. Mahdieh Hadavandkhani, Najmeh Foroughi-Heravani, Parisa Goodarzi, Moloud Payab, Hamid Reza Aghayan, Sepideh Alavi-Moghadam et al.
    Pages 107-116
  13. Najmeh Foroughi-Heravani, Mahdieh Hadavandkhani, Babak Arjmand, Moloud Payab, Fakher Rahim, Bagher Larijani et al.
    Pages 117-129
  14. Hamideh Moosapour, Asal Zarvani, Maryam Moayerzadeh, Bagher Larijani
    Pages 131-151
  15. Back Matter
    Pages 153-157

About this book

Introduction

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.


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

Editors and affiliations

  • Babak Arjmand
    • 1
  • Moloud Payab
    • 2
  • Parisa Goodarzi
    • 3
  1. 1.Cell Therapy and Regenerative Medicine Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences InstituteTehran University of Medical SciencesTehranIran
  2. 2.Obesity and Eating Habits Research Center, Endocrinology and Metabolism Molecular-Cellular Sciences InstituteTehran University of Medical SciencesTehranIran
  3. 3.Brain and Spinal Cord Injury Research Center, Neuroscience InstituteTehran University of Medical SciencesTehranIran

Bibliographic information

  • 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