Front Cover -- Dedication -- Reproductive And Developmental Toxicology -- Copyright -- Contents -- Foreword -- List of Contributors -- Section 1 - General -- Chapter 1 - Introduction -- Introduction -- Chapter 2 - Reproductive anatomy and physiology -- Introduction -- Important definitions and concepts -- Review of normal human reproduction -- Concluding remarks and future directions -- References -- Chapter 3 - Bio-communication between mother and offspring -- Introduction -- Maternal influences on the development of the offspring -- Transportation of bioactive substances between mother and offspring -- Concluding remarks and future directions -- References -- Chapter 4 - Pharmacokinetics in pregnancy -- Introduction -- Factors affecting pharmacokinetics in pregnancy -- The fetal compartment -- Maternal disease and obstetrical complications -- Origins of the knowledge gap -- Concluding remarks, current initiatives and future directions -- References -- Chapter 5 - PBPK models in reproductive and developmental toxicology -- Introduction -- PBPK Modeling: basic concepts and tools -- PBPK Modeling in reproductive and developmental toxicology -- PBPK Model applications in reproductive and developmental toxicology -- Concluding remarks and future directions -- References -- Chapter 6 - Transfer of drugs and xenobiotics through milk -- Introduction -- Drug excretion into breast milk -- Drug disposition in the infant -- Drugs that should be used with caution -- Non-medicinal substances -- Environmental pollutants -- Concluding remarks and future directions -- Acknowledgment -- References -- Section 2 - Safety Evaluation and Toxicity Testing Models -- Chapter 7 - Postmarket surveillance and regulatory considerations in reproductive and developmental toxicology: an FDA perspective -- Introduction -- Drugs intended for use in humans.

Vaccines intended for use in humans -- Drugs intended for use in animals -- References -- Chapter 8 - Reproductive and developmental safety evaluation of new pharmaceutical compounds -- Introduction -- Overview Of Human Pharmaceutical Development Process -- Developmental And Reproductive Toxicity (Dart) Studies Needed For Development Of Innovative Human Pharmaceuticals -- Interpretation Of Human Risk From The Reproductive And Developmental Toxicity Studies In Animals -- Reproductive Risks Communication And Management -- Concluding Remarks And Future Directions -- References -- Chapter 9 - Relevance of animal testing and sensitivity of endpoints in reproductive and developmental toxicity -- Introduction -- Choice of animal test models -- Non-mammalian animal models -- Endpoints of reproductive toxicity -- Tests and test guidelines -- Types of studies -- The path to alternative tests and conclusions -- References -- Chapter 10 - OECD guidelines and validated methods for in vivo testing of reproductive toxicity -- Introduction -- Method OECD 414 (prenatal developmental toxicity) -- Method OECD 415 (One-generation reproduction toxicity study) -- Method OECD 416 (two-generation reproduction toxicity study) -- Method OECD 421 (Reproduction/developmental toxicity screening test) -- Method OECD 422 (combined repeated dose toxicity study with the reproduction/developmental toxicity screening test) -- Method OECD 426 (Developmental neurotoxicity study) -- Other methods not included in the OECD -- Concluding remarks and future directions -- References -- Chapter 11 - Mechanism-based models in reproductive and developmental toxicology -- Introduction -- The necessity of alternative models for testing reproductive and developmental toxicology -- Validated alternative models for testing developmental toxicology.

Non-validated alternative models for testing developmental toxicology -- Concluding remarks and future directions -- References -- Chapter 12 - In vitro embryotoxicity testing -- Introduction -- In vitro models of embryotoxicity testing -- Early mouse and rat embryos as a model for embryotoxicity testing in vitro -- Definitions, revealed effects and their assessment criteria -- The methodical approaches of testing -- Conceptions and principles of in vitro embryotoxicity testing -- The evaluation of direct effects on cultured embryos -- Revealing and assessing embryotoxic factors in animal blood -- Study of the dynamics of embryotoxic factors in animal blood -- Concluding remarks and future directions -- References -- Chapter 13 - In vitro approaches to developmental neurotoxicity -- Introduction -- In vivo testing for neurotoxiCIty and developmental neurotoxicity -- In vitro approaches to developmental neurotoxicity -- Concluding remarks and future directions -- References -- Chapter 14 - Reproductive and developmental toxicity models in relation to neurodegenerative diseases -- Introduction -- Concluding remarks and future perspectives -- References -- Chapter 15 - Using zebrafish to assess developmental neurotoxicity -- Introduction -- Early development -- Vulnerability of the developing nervous system -- Adverse effects produced by developmental neurotoxicants -- Alternative animal models -- Practical considerations in zebrafish neurotoxicological research -- Zebrafish as a model of developmental neurotoxicity -- The importance of screens -- Screening approaches using larval zebrafish: some basic principles -- Zebrafish developmental neurotoxicity testing: screening large numbers of chemicals -- The zebrafish/human connection -- Concluding remarks and future directions -- Acknowledgment -- References.

Chapter 16 - Caenorhabditis elegans as a model to assess reproductive and developmental toxicity -- Introduction -- Background on C. elegans -- C. elegans and toxicity -- Molecular and cellular basis of developmental and reproductive toxicity in C. elegans -- Developmental and reproductive toxicity caused by metals -- Developmental and reproductive toxicity caused by pesticides -- Concluding remarks and future directions -- Acknowledgments -- References -- Chapter 17 - A primate as an animal model for reproductive and developmental toxicity testing -- Introduction -- Immunogenicity -- Developmental and reproductive toxicity studies -- Fertility study in NHP -- Embryo-fetal development study (ich 4.1.3) -- Pre- and postnatal development, including maternal function (ICH 4.1.2) -- Concluding remarks and future directions -- Acknowledgment -- References -- Chapter 18 - Developmental immunotoxicity testing -- Introduction -- Development of the immune system -- Developmental immunotoxicity testing paradigm -- Issues for risk assessment -- Concluding remarks and future directions -- References -- Chapter 19 - In vitro biomarkers of developmental neurotoxicity -- Introduction -- Cell proliferation and apoptosis -- Neurite outgrowth -- Neurotransmission/synaptogenesis -- Cytoskeleton -- Transcription factors and signaling pathways -- Concluding remarks and future directions -- References -- Chapter 20 - In vivo biomarkers and biomonitoring in reproductive and developmental toxicity -- Introduction -- Biomonitoring of exposure to pesticides -- Continual evolution of biomonitoring methods -- Biomarker selection and use -- Concluding remarks and future directions -- References -- Section 3 - Nanoparticles and Radiation -- Chapter 21 - Developmental toxicity of engineered nanoparticles -- Introduction.

Characteristics, production and applications of some engineered industrial nanomaterials -- Special features of nanomaterials in relation to their toxicity: oxidative stress and biopersistence -- Exposure and assessment of exposure to engineered nanomaterial -- Crossing biological barriers -- Potential mechanisms of action in developmental toxicology -- Health effects of engineered nanomaterials -- Developmental and reproductive toxicity -- Risk assessment of engineered nanomaterials including novel strategies and control banding -- Control banding -- Concluding remarks and future directions -- References -- Chapter 22 - Effects of radiation on the reproductive system -- Introduction -- Radiation dose and risk -- Radiation exposure and genetics hazards -- Radiation exposure and hypothalamus-pituitary-gonadal (hpg) axis dysfunction -- Radiation effects on male reproductive system -- Female reproductive functions and radiation effects -- Concluding remarks and future directions -- Acknowledgment -- References -- Section 4 - Gases and Solvents -- Chapter 23 - Reproductive and developmental toxicology: toxic solvents and gases -- Introduction -- Carbon tetrachloride (casrn 56-23-5) -- Tetrachloroethylene (casrn 127-18-4) -- Styrene (casrn 100-42-5) -- Toluene (casrn 108-88-3) -- Benzene (casrn 608-93-5) -- Gasoline (casrn 8006-61-9) -- Kerosene and jet fuels -- Formaldehyde (casrn 50-00-0) -- Concluding remarks and future directions -- Acknowledgments -- References -- Section 5 - Smoking, Alcohol, and Drugs of Abuse and Addiction -- Chapter 24 - Cigarette smoking and reproductive and developmental toxicity -- Introduction -- Historical background -- Pharmacokinetics/toxicokinetics -- Mechanisms of action -- Toxicity -- Treatment -- Concluding remarks and future directions -- References.

Chapter 25 - Effects of ethanol and nicotine on human CNS development.