Toxicokinetics and Risk Assessment

John C. Lipscomb, Edward V. Ohanian (Herausgeber)

Buch | Hardcover

382 Seiten

2006
Crc Press Inc (Verlag)
978-0-8493-3722-2 (ISBN)

Titel z.Zt. nicht lieferbar
Versandkostenfrei
Auch auf Rechnung

Artikel merken

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.

Lipscomb, John C.; Ohanian, Edward V.

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

Erscheint lt. Verlag	10.10.2006
Verlagsort	Bosa Roca
Sprache	englisch
Maße	152 x 229 mm
Gewicht	635 g
Themenwelt	Medizin / Pharmazie ► Allgemeines / Lexika
	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Studium ► 2. Studienabschnitt (Klinik) ► Pharmakologie / Toxikologie
	Naturwissenschaften ► Biologie ► Biochemie
ISBN-10	0-8493-3722-4 / 0849337224
ISBN-13	978-0-8493-3722-2 / 9780849337222
Zustand	Neuware