Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry

Lab on a Chip ◽  
2020 ◽  
Vol 20 (2) ◽  
pp. 215-225 ◽  
Author(s):  
Andreas R. Baudy ◽  
Monicah A. Otieno ◽  
Philip Hewitt ◽  
Jinping Gan ◽  
Adrian Roth ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Pharmaceutical Industry ◽  
Systems Development ◽  
End Users ◽  
Safety Risk ◽  
Microphysiological Systems

This pharmaceutical industry guidance based on a 3-staged benchmarking strategy aims to help MPS developers and end users identify what could be the most valuable models for safety risk assessment, as well as provide an overview of contexts of use.

scholarly journals Microphysiological Systems: Stakeholder Challenges to Adoption in Drug Development

2021 ◽  
pp. 1-13
Author(s):  
Passley Hargrove-Grimes ◽  
Lucie A. Low ◽  
Danilo A. Tagle
Keyword(s):  
Human Physiology ◽  
Pharmaceutical Industry ◽  
Drug Development ◽  
End Users ◽  
Regulatory Agencies ◽  
Functional Level ◽  
Multiple Stakeholder ◽  
Widespread Adoption ◽  
Microphysiological Systems

Microphysiological systems (MPS) or tissue chips/organs-on-chips are novel <i>in vitro</i> models that emulate human physiology at the most basic functional level. In this review, we discuss various hurdles to widespread adoption of MPS technology focusing on issues from multiple stakeholder sectors, e.g., academic MPS developers, commercial suppliers of platforms, the pharmaceutical and biotechnology industries, and regulatory organizations. Broad adoption of MPS technology has thus far been limited by a gap in translation between platform developers, end-users, regulatory agencies, and the pharmaceutical industry. In this brief review, we offer a perspective on the existing barriers and how end-users may help surmount these obstacles to achieve broader adoption of MPS technology.

Safety risk assessment and early warning of chemical contamination in vegetable oil

Food Control ◽  
2021 ◽  
Vol 125 ◽  
pp. 107970
Author(s):  
Bing Niu ◽  
Hui Zhang ◽  
Guangya Zhou ◽  
Shuwen Zhang ◽  
Yunfeng Yang ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Vegetable Oil ◽  
Early Warning ◽  
Chemical Contamination ◽  
Safety Risk
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