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Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies

Chapman, Kathryn and Chivers, Simon and Gliddon, Dan and Mitchell, David and Robinson, Sally and Sangster, Tim and Sparrow, Susan and Spooner, Neil and Wilson, Amanda (2014) Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies. Drug Discovery Today, 19 (5). pp. 528-532. ISSN 1878-5832

Abstract

Toxicokinetic analysis is an essential part of nonclinical drug development. Advances in bioanalytical techniques have opened up the potential to use smaller sample volumes (microsamples) to assess drug exposure in blood, plasma and/or serum. Microsampling can increase the amount of nonclinical safety information available, improve its validity by linking toxic effects to drug exposure in individual animals and represents the most significant opportunity to reduce animal use in toxicology studies in the short term. In May 2013, a workshop was held with 80 delegates from 33 companies with the aim of sharing information and knowledge on microsampling technologies. This article covers the discussions at the workshop, current practice in the industry, regulatory experiences and the future direction of microsampling across drug development. © 2014 The Authors.

Item Type: Article
Date Deposited: 21 Nov 2017 00:45
Last Modified: 25 Jan 2019 00:46
URI: https://oak.novartis.com/id/eprint/10930

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