Overcoming the barriers to the uptake of nonclinical microsampling in regulatory safety studies.
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.
National Centre for Replacement, Refinement and Reduction of Animals in Research, Gibbs Building, 215 Euston Road, London, NW1 2BE, UK. Electronic address: Kathryn.Chapman@nc3rs.org.uk.
Kathryn
K
Chapman
Novartis Biologics Safety & Disposition, WSJ-386.11.48.33, Novartis Institute for Biomedical Research, Basel CH-4002, Switzerland.
Simon
S
Chivers
Huntingdon Research Centre, Woolley Road, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UK.
Dan
D
Gliddon
Huntingdon Life Sciences Eye Research Centre, Suffolk, IP23 7PX, UK.
David
D
Mitchell
AstraZeneca Drug Safety and Metabolism, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Sally
S
Robinson
Charles River Laboratories, Bioanalysis & Immunology, Charles River, Tranent, Edinburgh, EH33 2NE, UK.
Tim
T
Sangster
GlaxoSmithKline General Toxicology, Ware, Hertfordshire, SG12 0DP, UK.
Susan
S
Sparrow
GlaxoSmithKline Drug Metabolism and Pharmacokinetics, Platform Technologies and Science, Ware, Hertfordshire, SG12 0DP, UK.
Neil
N
Spooner
AstraZeneca Drug Safety and Metabolism, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Amanda
A
Wilson
D000818:Animals; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000379:methods; D004353:Drug Evaluation, Preclinical / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000097:blood* / Q000175:diagnosis; D006801:Humans; D023421:Models, Animal