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. 2024 Oct 18;26(6):110.
doi: 10.1208/s12248-024-00975-x.

Case Studies on the use of Microsampling for Nonclinical Studies in Pharmaceutical Drug Discovery and Development

Shefali R Patel  1 , Jason Barricklow  2 , Peter Bryan  3 , Chiara Rospo  4 , Neil Spooner  5 , Ming Wang  6 , Joleen T White  7 , Amanda Wilson  8
Affiliations

Case Studies on the use of Microsampling for Nonclinical Studies in Pharmaceutical Drug Discovery and Development

Shefali R Patel et al. AAPS J. .

Abstract

The implementation of microsampling approaches for use in nonclinical discovery and development pharmaceutical studies can have a major impact on improving animal ethics through the use of fewer animals and less invasive procedures for the collection of toxicokinetic and pharmacokinetic samples. In addition, the approach offers the opportunity for obtaining improved quality of data for these studies. This can include the determination of additional timepoints and endpoints, and the ability to obtain exposure data from the same animals utilized to measure other study endpoints. This manuscript presents a number of cases where a variety of microsampling approaches have been successfully implemented by a number of organizations and serves as a guide for those considering the use of microsampling approaches as part of their drug discovery and development programs, as the adoption of these approaches are not yet universal.

Keywords: 3Rs; Animal ethics; Microsampling; Nonclinical.

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