Toxicokinetics and Risk Assessment (eBook, PDF)

Redaktion: Lipscomb, John C.; Ohanian, Edward V.

• Format: PDF

Produktbeschreibung

Toxicokinetics in Risk Assessment discusses the noncancer risk assessment process and its reliance on uncertainty factors in order to facilitate the continued study and refinement of the scientific basis for health risk assessment. This text clearly demonstrates the application of physiologically-based pharmacokinetic (PBPK) modeling in human health risk assessment, as well as methods for data generation, extrapolation, and inclusion of laboratory results for chemical metabolism and computer-based predictions of biochemical constants to address estimates of variability between experimental animals and humans. This guide also includes recent examples of the use of toxicokinetic information to successfully replace default values for uncertainty factors with data-derived factors in risk assessments developed by the US Environmental Protection Agency.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 361
• Erscheinungstermin: 19. April 2016
• Englisch
• ISBN-13: 9781420019308
• Artikelnr.: 53217601

Autorenporträt

Lipscomb, John C.; Ohanian, Edward V.

Inhaltsangabe

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