Review and evaluation of the potential impact of age-and gender-specific pharmacokinetic differences on tissue dosimetry

HJ Clewell, J Teeguarden, T McDonald… - Critical reviews in …, 2002 - Taylor & Francis
In standard risk assessment methods for carcinogenic or noncarcinogenic chemicals,
quantitative methods for evaluating interindividual variability are not explicitly considered …

Evaluation of the potential impact of age-and gender-specific pharmacokinetic differences on tissue dosimetry

HJ Clewell, PR Gentry, TR Covington… - Toxicological …, 2004 - academic.oup.com
The physiological and biochemical processes that determine the tissue concentration time
courses (pharmacokinetics) of xenobiotics vary, in some cases significantly, with age and …

Approaches for applications of physiologically based pharmacokinetic models in risk assessment

CM Thompson, B Sonawane, HA Barton… - Journal of Toxicology …, 2008 - Taylor & Francis
Physiologically based pharmacokinetic (PBPK) models are particularly useful for simulating
exposures to environmental toxicants for which, unlike pharmaceuticals, there is often little …

Evaluation of the potential impact of pharmacokinetic differences on tissue dosimetry in offspring during pregnancy and lactation

PR Gentry, TR Covington, HJ Clewell III - Regulatory Toxicology and …, 2003 - Elsevier
In recent years efforts have increased to develop a framework for assessing differences,
both pharmacokinetic and pharmacodynamic, between children and adults for purposes of …

A consistent approach for the application of pharmacokinetic modeling in cancer and noncancer risk assessment.

HJ Clewell 3rd, ME Andersen… - Environmental Health …, 2002 - ehp.niehs.nih.gov
Physiologically based pharmacokinetic modeling provides important capabilities for
improving the reliability of the extrapolations across dose, species, and exposure route that …

Evaluation of child/adult pharmacokinetic differences from a database derived from the therapeutic drug literature

G Ginsberg, D Hattis, B Sonawane, A Russ… - Toxicological …, 2002 - academic.oup.com
Pharmacokinetics (PK) of xenobiotics can differ widely between children and adults due to
physiological differences and the immaturity of enzyme systems and clearance mechanisms …

Utility of life stage-specific chemical risk assessments based on New Approach Methodologies (NAMs)

P Gonnabathula, MK Choi, M Li, SV Kabadi… - Food and Chemical …, 2024 - Elsevier
The safety assessments for chemicals targeted for use or expected to be exposed to specific
life stages, including infancy, childhood, pregnancy and lactation, and geriatrics, need to …

Development and specification of physiologically based pharmacokinetic models for use in risk assessment

RA Clewell, HJ Clewell III - Regulatory Toxicology and Pharmacology, 2008 - Elsevier
Risk assessments are performed to estimate the conditions under which individuals or
populations may be harmed by exposure to environmental or occupational chemicals. In the …

Evaluation of physiologically based pharmacokinetic models for use in risk assessment

WA Chiu, HA Barton, RS DeWoskin… - Journal of Applied …, 2007 - Wiley Online Library
Physiologically based pharmacokinetic (PBPK) models are sophisticated dosimetry models
that offer great flexibility in modeling exposure scenarios for which there are limited data …

The application of physiologically based pharmacokinetic modeling in human health risk assessment of hazardous substances

HJ Clewell III - Toxicology letters, 1995 - Elsevier
Physiologically based pharmacokinetic (PBPK) modeling is an important tool for improving
the accuracy of human health risk assessments for hazardous substances in the …