Risk Assessment of Prenatally-Induced Adverse Health Effects

Front Matter....Pages I-XIV
Introduction....Pages 1-23
Front Matter....Pages 25-25
Risk Assessment for Pharmaceutical Products....Pages 27-43
Reproductive Toxicity Risk Assessment — Some Questions....Pages 45-61
Biomarkers of Developmental Neurotoxicity....Pages 63-77
A Call for Increased Flexibility in Current Teratogenicity Testing....Pages 79-84
Specific and Non-Specific Developmental Effects....Pages 85-100
Front Matter....Pages 101-101
Assessment of Reproductive Toxicology of Drugs at the Food and Drug Administration....Pages 103-111
New Approaches to Developmental Toxicity Risk Assessment at the U.S. Environmental Protection Agency....Pages 113-126
Scientific Basis for Risk Assessment (Reproductive Toxicity) for Pesticides as Practiced by the Bundesgesundheitsamt (BGA)....Pages 127-139
Scientific Basis for Risk Assessment (Reproductive Toxicity) in Ecotoxicology as Practiced by the Federal Environmental Agency (Umweltbundesamt)....Pages 141-148
General Discussion: Choice of Species....Pages 149-151
Scientific Basis for Risk Assessment (Reproductive Toxicity) for Medicinal Products as Practiced in Germany and the European Community (EC)....Pages 153-161
Risk Assessment in Reproductive Toxicology as Practiced in South America....Pages 163-179
Reproductive Hazard Evaluation and Risk Assessment under California’s Proposition 65....Pages 181-189
General Discussion: Risk Assessment....Pages 191-194
Front Matter....Pages 195-195
Statistical Problems (and Some Solutions) Associated with Testing for Effects in Developmental Toxicology....Pages 197-209
Aspects of Concentration-Response Analysis....Pages 211-226
Dose-Response Relationships in Reproductive Toxicology: Importance of Skeletal Variations for Risk Assessment....Pages 227-244
Prenatal-Toxic Risk Estimation Based on Dose-Response Relationships and Molecular Dosimetry....Pages 245-266
Kinetic Problems Arising in a Multigeneration Study....Pages 267-278
Front Matter....Pages 195-195
Application of Mathematical Dose-Response Models vs. Physiological Models in Risk Assessment in Reproductive Toxicology....Pages 279-287
General Discussion: Use of Biologically Based Models....Pages 289-290
Front Matter....Pages 291-291
Pharmacokinetics and Drug Metabolism in the Design and Interpretation of Developmental Toxicity Studies....Pages 293-312
Feasibility of Studying Effects on the Immune System in Non-Human Primates....Pages 313-346
Marmosets ( Callithrix jacchus ) as Useful Species for Toxicological Risk Assessments....Pages 347-376
Planning and Performance of Segment I, II and III Experiments: Practical Aspects and General Comments....Pages 377-387
Significance of Postnatal Manifestations of Prenatally-Induced Effects (Behaviour)....Pages 389-396
Significance of Prenatally or Early Postnatally-Induced Organ Dysfunctions — Other than CNS Defects....Pages 397-417
Quantitative Morphological Tests for Evaluation of Testicular Toxicity....Pages 419-431
Morphological Changes in Cultures of Hippocampus Following In Vitro Irradiation....Pages 433-448
Possible Contribution of In Vitro Methods to Risk Assessment in Reproductive and Developmental Toxicology....Pages 449-473
Morphological Endpoints in In Vitro Testing....Pages 475-486
Front Matter....Pages 487-487
Significance of Epidemiological Studies for Risk Assessment in Prenatal Toxicity....Pages 489-501
Maternal Thyroid Autoantibodies and Fetal Thyroid Growth....Pages 503-512
Pre- and Postnatal Risk Factors for the Development of Atopy in Childhood....Pages 513-518
Does Smoking During Pregnancy Alter Brain Perfusion in the Neonate? A Doppler Study....Pages 519-526
Risk Assessment of Tocolytic Therapy in Pregnancy....Pages 527-535
Histochemical and Immunocytochemical Investigations of the Fetal Extravascular and Vascular Contractile System in the Normal Placenta and During Preeclampsia....Pages 537-550
Some Data on the Pattern of Lymphocyte Subsets in Blood During the Perinatal Period....Pages 551-560
Back Matter....Pages 561-565