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Titlebook: Biomedical Product Development: Bench to Bedside; Babak Arjmand,Moloud Payab,Parisa Goodarzi Textbook 2020 Springer Nature Switzerland AG

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楼主: miserly
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https://doi.org/10.1007/978-0-387-78864-7rdingly, good clinical practice (GCP) is an international ethical and scientific quality standard for conducting the trials involving human subjects. In this chapter, a brief history of GCP, leading to its importance and functions, will be discussed. Then, we will go through some details about its p
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https://doi.org/10.1007/978-0-387-78864-7ities. Accordingly, in this chapter, all aspects of GCP will be discussed in detail. Before conducting the trial, there are some requirements such as justification of the research – especially ethical wise – and establishment of procedures for documentation. Further, the risk management processes an
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https://doi.org/10.1007/978-0-387-78864-7, Tuskegee, Willowbrook, Milgram, Stanford Prison, etc.). Tuskegee Syphilis Study, for instance, is conducted by the U.S. Public Health Service (1932–1972). In this study, 400 subjects out of 600 African-American males from a low social economic population were infected with syphilis and observed fo
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https://doi.org/10.1007/978-0-387-78864-7d is safety. Challenges of safety consideration and efficacy of human cell-based products need to be further addressed. Safety concerns depend on many risk factors including intrinsic, extrinsic, and associated with clinical characteristics. This chapter explains importance of safety. Thereafter, several risk factors will be described.
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https://doi.org/10.1007/978-0-387-78864-7ducts (HCTPs) in their structure, content, mode of action, and delivery confronts health relevant professionals, regulatory authorities, and manufacturers with some challenges from product design to delivery [1].
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https://doi.org/10.1007/978-0-387-78864-7This chapter is trying to learn:
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