Biomedical product development : bench to bedside /

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Bibliographic Details
Imprint:Cham, Switzerland : Springer, 2020.
Description:1 online resource (xiv, 157 pages) : color illustrations
Language:English
Series:Learning materials in biosciences, 2509-6125
Learning materials in biosciences,
Subject:
Format: E-Resource Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/12603762
Hidden Bibliographic Details
Other authors / contributors:Arjmand, Babak, editor.
Payab, Moloud, editor.
Goodarzi, Parisa, editor.
ISBN:9783030356262
3030356264
9783030356255
3030356256
Notes:Includes index.
Online resource; title from PDF title page (SpringerLink, viewed February 26, 2020).
Summary: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.
Other form:Print version: 3030356256 9783030356255
Standard no.:10.1007/978-3-030-35626-2