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

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Safety Concerns and Requirement of Cell-Based Products for Clinical Application,d 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.

GLIB

Standards and Regulatory Frameworks (for Cell- and Tissue-Based Products),ducts (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].

LASH

https://doi.org/10.1007/978-0-387-78864-7940s. Quality in the laboratory means to have a traceable and accurate test results. Accordingly, any level of inaccuracy should be avoided. On the other hand, in the field of biomedical product manufacturing, achieving a safe and efficient product needs implementing all of the aspects of the qualit

水土

https://doi.org/10.1007/978-0-387-78864-7ology laboratories and increase the number of laws for chemical and pharmaceutical products [1]. They discovered a lot of fraudulent activities and poor laboratory practices such as uncalibrated equipment, wrong measurements, inaccurate data, and inadequate test systems. Accordingly, by setting GLP

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spondylosis

https://doi.org/10.1007/978-0-387-78864-7 hormones affect the human body? Unfortunately, it is not usually possible to address these questions through performing relevant tests on human population. Hence, developing animal models which properly mimic the human pathophysiology to generate different human disease situations is a suitable alt

Parameter

https://doi.org/10.1007/978-0-387-78864-7ustrial revolution altered the concept of quality drastically. Rise of inspections and separation of quality departments were the main outcomes of this alteration. On the other hand, statistical methods were the unprecedented approach to control the products variabilities and quality. In addition to

NOCT

雪白

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].