This volume provides the reader with a comprehensive overview of the routine and special toxicologic assessments performed on pharmaceutical agents, chemicals, pesticides and consumer products. Toxicity testing procedures will be described emphasizing experimental design considerations (dose and species selection, toxicokinetic criteria) as well as regulatory guidelines and impacts of global harmonization efforts. The volume also provides insights into the risk assessment process in terms of evaluating and interpreting toxicity data relative to human safety.
Table of Contents
Introduction (P.D. Williams, G.H. Hottendorf✠). Safety assessment of pharmaceuticals (R.M. Diener). Risk assessment of pesticides (J.T. Stevens). Risk assessment of consumer products (H. North-Root). Occupational Toxicology Testing (E.V. Sargent, B. Nauman, C.S. Schwartz, G.L. Spraque). Assessing risks to human health (R.D. Thomas). Standards of good practice for the conduct of regulated nonclinical safety studies (P.L. Gittelson, P.D. Lepore). Animal care and use in toxicity testing (T.E. Hickey). Acute, subchronic, and chronic toxicity studies (W.M. Weatherholtz). Carcinogenicity studies (F.E. Reno). Genetic toxicology (J.W. Oldham). Reproductive and developmental toxicology studies (M.S. Christian). Major organ systems toxicology: an integrated approach to pharmacodynamic safety assessment studies in animals (L.B. Kinter, D.J. Murphy, W.A. Mann, T.B. Leonard, G. Morgan). Toxicokinetics and toxicodynamics (D.E. Johnson, G.H.I. Wolfgang, M.A. Gledin, R.A. Braeckman). Human clinical safety assessment procedures (E.J. Fox). Statistical methods in toxicology (S.C. Gad). The role of investigative techniques in toxicity testing (R.G. Ulrich, J.G. Slatter). Use of animal models in biomedical research (J.A. Thomas). Ocular and dermal studies (S.C. Gad). Immunotoxicity studies (D.A. Neumann). Inhalation toxicity studies (R.K. Wolff, M.A. Dorato). Considerations in the preclinical evaluation of biotechnology-derived products (J.A. Cavagnaro). Safety testing of antitumor agents (J.E. Tomaszewski, A.C. Smith). Considerations in evaluating toxicity data (G.H. Hottendorf✠, P.D. Williams).