Abstract
Toxicokinetics is defined as “the generation of pharmacokinetic data, either as an integral component in the conduct of nonclinical toxicity studies or in specially designed supportive studies, in order to assess systemic exposure. These data may be used in the interpretation of toxicology findings and their relevance to clinical safety issues” (ICH Guidance Toxicokinetics 1994).
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References and Further Reading
Barfield M et al (2008) Application of dried blood spots combined with HPLC-MS/MS for the quantification of acetaminophen in toxicokinetic studies. J Chromatogr B 870:32–37
Beharry M (2010) DBS: a UK (MHRA) regulatory perspective. Bioanalysis 2:1363–1364
Burnett JEC (2011) Dried blood spot sampling: practical considerations and recommendation for use with preclinical studies. Bioanalysis 3:1099–1107
BVA/FrAME/RSPCA/UFAW Working Group of Refinement (1993) Removal of blood from laboratory mammals and birds. Laboratory Animals 27:1–22
Cayen M-N (1995) Considerations in the design of toxicokinetic programs. Toxicol Pathol 23(2):148–157
Chollet DF, Goumaz L, Renard A et al (1998) Simultaneous determination of the lactone and carboxylate forms of the camptothecin derivative CPT-11 and its metabolite SN- 38 in plasma by high-performance liquid chromatography. J Chromatogr Biomed Appl 718(1):163–175
EMEA CHMP Guideline (2005) on the evaluation of control samples in nonclinical safety studies: Checking for contamination with the test substance (CPMP/SWP/1094/04)
Diehl K-H, Hull R, Morton D, Pfister R, Rabemampianina Y, Smith D, Vidal J-M, van de Vorstenbosch C (2001) A good practice guide to the administration of substances and removal of blood, including routes and volumes. J Appl Toxicol 21:15–23
Emmons G, Rowland M (2010) Pharmacokinetic considerations as to when to use dried blood spot sampling. Bioanalysis 2(11):1791–1796
Gluth WP, Sorgel F, Gluth B et al (1988) Determination of sotalol in human body fluids for pharmacokinetic and toxicokinetic studies using high-performance liquid chromatography. Arzneimittelforschung 38(3):408–411
ICH Guidance Toxicokinetics (1994) ICH Topic S 3 A; toxicokinetics: a guidance for assessing systemic exposure in toxicology studies (CPMP/ICH/384/95); approval by CPMP (November 94). http://www.emea.eu.int/pdfs/human/ich/038495en.pdf
Kawauchi T, Matsumoto H, Yano S (2001) Determination of a new thymidine phosphorylase inhibitor, TPI, in dog and rat plasma by reversed-phase ion-pair high-performance liquid chromatography. J Chromatogr Biomed Appl 751(2):325–330
Kim H, Schuessler DG, Bach CA et al (1999) High-performance liquid chromatographic analysis of the D4 receptor antagonist SCH 66712 in rat plasma. J Chromatogr B Biomed Sci Appl 735(1):11–18
Kim H, Kumari P, Lin CC, Nomeir AA (2002) Simultaneous high-performance liquid chromatographic determination of SCH 59884 (phosphate ester prodrug of SCH 56592), SCH 207962 and SCH 56592 in dog plasma. J Pharm Biomed Anal 27(1–2):295–303
Los LE, Welsh DA, Herold EG et al (1996) Gender differences in toxicokinetics, liver metabolism, and plasma esterase activity: observations from a chronic (27-week) toxicity study of enalapril/ditiazem combinations in rats. Drug Metab Dispos 24(1):28–33
Pai SM, Fettner SH, Hajian G, Cayen MN, Batra VK (1996) Characterization of AUCs from sparsely sampled populations in toxicology studies. Pharm Res 13(9):1283–1290
Shum YY, Black A, Chang T (1994) Determination of 2,2- dimethyl N-(2,4,6-trimethoxyphenyl) dodecanamide, C1–976, in rat plasma by reversed-phase high-performance liquid chromatography. J Chromatogr Biomed Appl 653(2):205–209
Timmerman P (2011) White paper: EBF recommendation on the validation of bioanalytical methods for dried blood spots. Bioanalysis 3:1567–1575
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer-Verlag Berlin Heidelberg
About this entry
Cite this entry
Lehr, KH. (2013). Bioanalytical Assays – Toxicokinetics. In: Vogel, H.G., Maas, J., Hock, F.J., Mayer, D. (eds) Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-25240-2_37
Download citation
DOI: https://doi.org/10.1007/978-3-642-25240-2_37
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-25239-6
Online ISBN: 978-3-642-25240-2
eBook Packages: Biomedical and Life SciencesReference Module Biomedical and Life Sciences