Abstract
Toxicokinetics is an integral component of toxicological studies in order to interrelate the administered dose with the associated effect. Pharmacokinetic data are essential for judging absorption, bioavailability, and bioefficacy across routes, regimens, and species. In case substances are administered by inhalation, it provides a means to identify substance accumulation and clearance in the lung. Also in other disciplines of toxicology, toxicokinetics is important for the assessment of persistence and bioaccumulation. Toxicokinetics includes analyses of temporal change of concentration profiles of the parent substance, its metabolites, or degradation products. Accordingly, toxicokinetic data provide indispensable estimates for systemic and organ-specific substance burdens and contribute significantly to the interpretation of toxicological data and their significance for humans.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Pauluhn J (2002) Aniline-induced methemoglobinemia in dogs: pitfalls of route-to-route extrapolations. Inhal Toxicol 14:959–973
Pauluhn J, Rosenbruch M (2003) Inhalation toxicity of propineb. Part I: results of subacute inhalation exposure studies in rats. Inhal Toxicol 5:411–434
Pauluhn J (2010) Multi-walled Carbon Nanotubes (Baytubes®): Approach for Derivation of Occupational Exposure Limit. Regulatory Pharmacology and Toxicology 57:78–89
Pauluhn J (2011) Poorly Soluble Particulates: Searching for a Unifying Denominator of Nanoparticles and Fine Particles for DNEL Estimation. Toxicology 279:176–188.
Pauluhn J, Wiemann, M (2011) Siderite (FeCO3) and Magnetite (Fe3O4) Overload-Dependent Pulmonary Toxicity is determined by the Poorly Soluble Particle, not the Iron-Content. Inhalation Toxicology 23:763–783
Recommended Reading
Environmental Protection Agency (EPA) (1994) Method for derivation of inhalation reference concentrations and application of inhalation dosimetry. United States Environmental Protection Agency, Washington, DC, EPA/600/8-90/066F
Milton MN, Christopher J (2009) Horvath the EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development. Toxicol Pathol 37:363–371
Zhang D, Comezoglu SN (2008) Chapter 18. ADME studies in animals and humans: experimental design, metabolite profiling and identification, and data presentation. In: Zhang D, Zhu M, Griffith Humphreys W (eds) Drug metabolism in drug design and development: basic concepts and practice. Wiley, Hoboken, pp 503–604. Food and Drug Administration. http://www.fda.gov/cder/guidance/index.htm
Resources
REACH-Guidance on information requirements and chemical safety assessment, Chapter R.7c: endpoint specific guidance Chapter R.11: PBT assessment. http://echa.europa.eu/documents/
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer-Verlag Berlin Heidelberg
About this entry
Cite this entry
Pauluhn, J. (2014). Toxicokinetic Tests. In: Reichl, FX., Schwenk, M. (eds) Regulatory Toxicology. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-35374-1_38
Download citation
DOI: https://doi.org/10.1007/978-3-642-35374-1_38
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-35373-4
Online ISBN: 978-3-642-35374-1
eBook Packages: Biomedical and Life SciencesReference Module Biomedical and Life Sciences