Overview of the Approach to Noncancer Risk Assessment | |
Guidance for the Development of Chemical Specific Adjustment Factors: Integration with Mode of Action Frameworks | |
Derivation and Modeling of Mechanistic Data for Use in Risk Assessment | |
Empirically Observed Distributions of Pharmacokinetic and Pharmacodynamic Variability in Humans-Implications for the Derivation of Single Point Component Uncertainty Factors Providing Equivalent Protection as Existing RFDs | |
Use of Classical Pharmacokinetic Evaluations in Drug Development and Safety Assessment | |
Considerations for Applying Physiologically Based Pharmacokinetic Models in Risk Assessment | |
Considerations of Design and Data when Developing Physiologically Based Pharmacokinetic Models | |
In Silico Predictions of Partition Coefficients for Physiologically Based Pharmacokinetic Models | |
In Vitro to In Vivo Extrapolation of Metabolic Rate Constants for Physiologically Based Pharmacokinetic Models | |
Use of Physiologically Based Pharmacokinetic Modeling to Evaluate Implications of Human Variability | |
Developmental Aspects of Children's Pharmacokinetics | |
Sensitive Populations and Risk Assessment | |
Statistical Issues in Physiologically Based Pharmacokinetic Modeling | |
Drug Development and the Use of Pharmacokinetics/Toxicokinetics in Selecting the First Dose of Systemically Administered Drugs in Humans-A Nonclinical Perspective | |
Pharmacokinetic/PBPK Models in IRIS Assessments | |
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