Automated DBS microsampling, microscale automation and microflow LC-MS for therapeutic protein PK.
Bioanalysis
; 8(7): 649-59, 2016 Apr.
Article
em En
| MEDLINE
| ID: mdl-26977979
ABSTRACT
AIM:
Reduce animal usage for discovery-stage PK studies for biologics programs using microsampling-based approaches and microscale LC-MS. METHODS &RESULTS:
We report the development of an automated DBS-based serial microsampling approach for studying the PK of therapeutic proteins in mice. Automated sample preparation and microflow LC-MS were used to enable assay miniaturization and improve overall assay throughput. Serial sampling of mice was possible over the full 21-day study period with the first six time points over 24 h being collected using automated DBS sample collection. Overall, this approach demonstrated comparable data to a previous study using single mice per time point liquid samples while reducing animal and compound requirements by 14-fold.CONCLUSION:
Reduction in animals and drug material is enabled by the use of automated serial DBS microsampling for mice studies in discovery-stage studies of protein therapeutics.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Proteínas
Limite:
Animals
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article