Towards in vitro models for reducing or replacing the use of animals in drug testing

David M Stresser^{1

2

3}, Anna K Kopec^{4

5

6}, Philip Hewitt^{4

5

7}, Rhiannon N Hardwick^{4

5

8}, Terry R Van Vleet^{4

5

9}, Prathap Kumar S Mahalingaiah^{4

5

9}, Denice O'Connell^{4

10

11}, Gary J Jenkins^{12

4

13}, Rhiannon David^{4

5

14}, Jessica Graham^{4

15

16

17}, Donna Lee^{4

11

17}, Jason Ekert^{4

5

18}, Aaron Fullerton^{4

5

19}, Remi Villenave^{4

5

20}, Piyush Bajaj^{4

5

21}, James R Gosset^{4

5

22}, Sherry L Ralston^{4

11

23}, Manti Guha^{4

5

24}, Alejandro Amador-Arjona^{4

5

24}, Kainat Khan^{4

5

14}, Saket Agarwal^{4

5

25}, Catrin Hasselgren^{4

16

26}, Xiaoting Wang^{4

5

27}, Khary Adams^{4

11

28}, Gaurav Kaushik^{4

5

29}, Arkadiusz Raczynski^{4

5

30}, Kimberly A Homan^{31

32

33}

Affiliations

¹ Quantitative, Translational & ADME Sciences, AbbVie, North Chicago, IL, USA. david.stresser@abbvie.com.
² International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), . david.stresser@abbvie.com.
³ IQ Microphysiological Systems Affiliate (IQ-), . david.stresser@abbvie.com.
⁴ International Consortium for Innovation and Quality in Pharmaceutical Development (IQ).
⁵ IQ Microphysiological Systems Affiliate (IQ-).
⁶ Drug Safety Research & Development, Pfizer, Inc., Groton, CT, USA.
⁷ Chemical and Preclinical Safety, Merck KGaA, Darmstadt, Germany.
⁸ Discovery Toxicology, Pharmaceutical Candidate Optimization, Bristol Myers Squibb, San Diego, CA, USA.
⁹ Investigative Toxicology and Pathology, AbbVie, North Chicago, IL, USA.
¹⁰ Global Animal Welfare, AbbVie, North Chicago, IL, USA.
¹¹ IQ 3Rs (Replacement, Reduction, Refinement) Translational and Predictive Sciences Leadership Group.
¹² Quantitative, Translational & ADME Sciences, AbbVie, North Chicago, IL, USA.
¹³ IQ Translational and ADME Sciences Leadership Group (TALG).
¹⁴ Clinical Pharmacology & Safety Sciences, AstraZeneca, Cambridge, UK.
¹⁵ Product Quality & Occupational Toxicology, Genentech, Inc., South San Francisco, CA, USA.
¹⁶ IQ DruSafe.
¹⁷ Safety Assessment, Genentech, Inc., South San Francisco, CA, USA.
¹⁸ UCB Pharma, Cambridge, MA, USA.
¹⁹ Investigative Toxicology, Genentech, Inc., South San Francisco, CA, USA.
²⁰ Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
²¹ Global Investigative Toxicology, Preclinical Safety, Sanofi, Cambridge, MA, USA.
²² Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Pfizer, Inc, Cambridge, MA, USA.
²³ Preclinical Safety, AbbVie, North Chicago, IL, USA.
²⁴ Discovery Biology, Incyte, Wilmington, DE, USA.
²⁵ Investigative Toxicology, Early Development, Alnylam Pharmaceuticals, Cambridge, MA, USA.
²⁶ Predictive Toxicology, Genentech, Inc., South San Francisco, CA, USA.
²⁷ Translational Safety & Bioanalytical Sciences, Amgen Research, Amgen Inc., South San Francisco, CA, USA.
²⁸ Laboratory Animal Resources, Incyte, Wilmington, DE, USA.
²⁹ Nonclinical Drug Safety, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
³⁰ Preclinical Safety Assessment, Vertex Pharmaceuticals, Inc, Boston, MA, USA.
³¹ International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), . homan.kimberly@gene.com.
³² IQ Microphysiological Systems Affiliate (IQ-), . homan.kimberly@gene.com.
³³ Complex in vitro Systems Group, Genentech, Inc., South San Francisco, CA, USA. homan.kimberly@gene.com.

PMID: 38151640
DOI: 10.1038/s41551-023-01154-7

Towards in vitro models for reducing or replacing the use of animals in drug testing

David M Stresser et al. Nat Biomed Eng. 2024 Aug.

. 2024 Aug;8(8):930-935.

doi: 10.1038/s41551-023-01154-7.

Authors

Affiliations

¹ Quantitative, Translational & ADME Sciences, AbbVie, North Chicago, IL, USA. david.stresser@abbvie.com.
² International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), . david.stresser@abbvie.com.
³ IQ Microphysiological Systems Affiliate (IQ-), . david.stresser@abbvie.com.
⁴ International Consortium for Innovation and Quality in Pharmaceutical Development (IQ).
⁵ IQ Microphysiological Systems Affiliate (IQ-).
⁶ Drug Safety Research & Development, Pfizer, Inc., Groton, CT, USA.
⁷ Chemical and Preclinical Safety, Merck KGaA, Darmstadt, Germany.
⁸ Discovery Toxicology, Pharmaceutical Candidate Optimization, Bristol Myers Squibb, San Diego, CA, USA.
⁹ Investigative Toxicology and Pathology, AbbVie, North Chicago, IL, USA.
¹⁰ Global Animal Welfare, AbbVie, North Chicago, IL, USA.
¹¹ IQ 3Rs (Replacement, Reduction, Refinement) Translational and Predictive Sciences Leadership Group.
¹² Quantitative, Translational & ADME Sciences, AbbVie, North Chicago, IL, USA.
¹³ IQ Translational and ADME Sciences Leadership Group (TALG).
¹⁴ Clinical Pharmacology & Safety Sciences, AstraZeneca, Cambridge, UK.
¹⁵ Product Quality & Occupational Toxicology, Genentech, Inc., South San Francisco, CA, USA.
¹⁶ IQ DruSafe.
¹⁷ Safety Assessment, Genentech, Inc., South San Francisco, CA, USA.
¹⁸ UCB Pharma, Cambridge, MA, USA.
¹⁹ Investigative Toxicology, Genentech, Inc., South San Francisco, CA, USA.
²⁰ Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd, Basel, Switzerland.
²¹ Global Investigative Toxicology, Preclinical Safety, Sanofi, Cambridge, MA, USA.
²² Pharmacokinetics, Dynamics and Metabolism, Medicine Design, Pfizer, Inc, Cambridge, MA, USA.
²³ Preclinical Safety, AbbVie, North Chicago, IL, USA.
²⁴ Discovery Biology, Incyte, Wilmington, DE, USA.
²⁵ Investigative Toxicology, Early Development, Alnylam Pharmaceuticals, Cambridge, MA, USA.
²⁶ Predictive Toxicology, Genentech, Inc., South San Francisco, CA, USA.
²⁷ Translational Safety & Bioanalytical Sciences, Amgen Research, Amgen Inc., South San Francisco, CA, USA.
²⁸ Laboratory Animal Resources, Incyte, Wilmington, DE, USA.
²⁹ Nonclinical Drug Safety, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
³⁰ Preclinical Safety Assessment, Vertex Pharmaceuticals, Inc, Boston, MA, USA.
³¹ International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), . homan.kimberly@gene.com.
³² IQ Microphysiological Systems Affiliate (IQ-), . homan.kimberly@gene.com.
³³ Complex in vitro Systems Group, Genentech, Inc., South San Francisco, CA, USA. homan.kimberly@gene.com.

PMID: 38151640
DOI: 10.1038/s41551-023-01154-7

No abstract available

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References

1. Avila, A. M. et al. Regul. Toxicol. Pharmacol. 139, 105345 (2023). - PubMed - DOI
1. ICH Guideline M3(R2) on Non-clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorisation for Pharmaceuticals: Step 5 (European Medicines Agency, 2013).
1. Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program (US Environmental Protection Agency, 2018).
1. A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States (ICCVAM, 2018).
1. Avila, A. M. et al. Regul. Toxicol. Pharmacol. 114, 104662 (2020). - PubMed - DOI

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Towards in vitro models for reducing or replacing the use of animals in drug testing

Affiliations

Towards in vitro models for reducing or replacing the use of animals in drug testing

Authors

Affiliations

References

MeSH terms

LinkOut - more resources

Full Text Sources