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

Author:

Baudy Andreas R.123ORCID,Otieno Monicah A.453,Hewitt Philip678,Gan Jinping9103ORCID,Roth Adrian111213,Keller Douglas143ORCID,Sura Radhakrishna15163,Van Vleet Terry R.15163,Proctor William R.17183

Affiliation:

1. Merck & Co., Inc.

2. Kenilworth

3. USA

4. Janssen Pharmaceutical Research and Development

5. Spring House

6. Merck KGaA

7. Darmstadt

8. Germany

9. Bristol-Myers Squibb

10. New York City

11. Roche Innovation Centre

12. Basel

13. Switzerland

14. Sanofi, Bridgewater

15. AbbVie, Inc.

16. Chicago

17. Genentech, Inc.

18. South San Francisco

Abstract

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.

Publisher

Royal Society of Chemistry (RSC)

Subject

Biomedical Engineering,General Chemistry,Biochemistry,Bioengineering

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