Format:
1 Online-Ressource (1462 pages)
ISBN:
9780128042403
Content:
Front Cover -- REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY -- REPRODUCTIVE AND DEVELOPMENTAL TOXICOLOGY -- Copyright -- Contents -- List of Contributors -- I - GENERAL -- 1 - Introduction -- Reference -- 2 - Reproductive Anatomy and Physiology -- INTRODUCTION -- IMPORTANT DEFINITIONS AND CONCEPTS -- Reproduction -- Hormones and Hormone Receptors -- Gonadal Steroid Hormones and Their "Nuclear" Receptors -- Genomic and Nongenomic Mechanisms of Action of Gonadal Steroid Hormones -- REVIEW OF NORMAL HUMAN REPRODUCTION -- Historical Perspectives and Complexity of Reproductive Function -- Relevance of a Basic Understanding of Human Reproductive Anatomy and Physiology -- Neuroendocrine Control of Reproduction -- Puberty and Sexual Maturity -- The Onset of Puberty -- The Endocrinology of Puberty -- Normal Male Reproductive Anatomy and Physiology -- Developmental Perspectives -- Reproductive Anatomy of the Male -- Testicular Structure -- Excurrent Duct System -- Accessory Sex Glands -- External Genitalia -- Spermatogenesis -- Proliferation (Mitosis or Spermatocytogenesis) -- Meiosis -- Differentiation (Spermiogenesis) -- The Cycle of the Seminiferous Epithelium -- Male Reproductive Physiology -- Gonadal Steroid Synthesis in the Testes -- Endocrine Regulation of Spermatogenesis -- Positive and Negative Feedback Loops Involved in Male Reproduction -- Epididymal and Accessory Sex Gland Function -- Sexual Behavior, Erection, Emission, and Ejaculation -- Normal Female Reproductive Anatomy and Physiology -- Developmental Perspectives -- Reproductive Anatomy of the Female -- Female Reproductive Physiology -- The Estrous Cycle -- The Menstrual Cycle -- Follicular Development -- Ovarian Follicular Synthesis of Estrogens -- The Effects of Estrogenic Feedback on the Hypothalamic-Pituitary-Gonadal Axis -- Ovulation -- Formation and Function of a Corpus Luteum
Content:
Summary of the Effects of Estrogens and Progesterone During the Female Reproductive Cycle -- Oocyte/Sperm Transport, Normal Capacitation of Sperm, and Fertilization -- Transport of the Ovulated Oocyte -- Transport and Capacitation of Spermatozoa -- Transport of Spermatozoa -- Capacitation of Spermatozoa -- Fertilization -- Important Aspects of Normal Embryonic and Fetal Development -- Historical Perspective -- Blastocyst Formation and Differentiation of the Germ Cell Layers -- "Maternal Recognition of Pregnancy" and Implantation -- Formation of the Extraembryonic Membranes -- Concepts and Definitions -- Placental Types -- Placental Function -- The "Placental Barrier" -- Sex Determination and Sexual Differentiation of Reproductive Function -- Genotypic Sex and Development of the Primitive Sex Cords -- Gonadal Sex Determination and Phenotypic Sexual Differentiation -- Development of the Male Phenotype -- Development of the Female Phenotype -- Sexual Differentiation of the Brain -- The Endocrinology of Pregnancy -- Gestational Hormones -- Parturition -- Physiology of Parturition -- The Mammary Glands -- Anatomy -- Physiology of Lactation -- Lactogenesis -- Control of Prolactin Secretion -- Reproductive Senescence -- CONCLUDING REMARKS AND FUTURE DIRECTIONS -- References -- 3 - Pharmacokinetics in Pregnancy -- INTRODUCTION -- FACTORS AFFECTING PHARMACOKINETICS IN PREGNANCY -- Absorption -- Distribution -- Metabolism -- Renal Excretion -- THE FETAL COMPARTMENT -- Drug Metabolism Within the Fetal Compartment -- Drug Accumulation Within the Fetal Compartment -- HIGHLIGHTING THE VALUE OF PK INFORMATION IN PREGNANCY: TOCOLYTIC THERAPY -- MATERNAL DISEASE AND OBSTETRICAL COMPLICATIONS -- ORIGINS OF THE KNOWLEDGE GAP -- CURRENT INITIATIVES AND FUTURE DIRECTIONS -- PHYSIOLOGICALLY BASED PHARMACOKINETIC MODELING -- CONCLUDING REMARKS AND FUTURE DIRECTIONS
Content:
References -- 4 - Physiologically Based Pharmacokinetic 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 -- 5 - Drugs and Chemical Contaminants in Human Breast Milk -- INTRODUCTION -- BREAST-FEEDING -- DRUG EXCRETION INTO BREAST MILK -- Maternal Pharmacokinetics in the Postpartum Period -- Drug Medications Interfering With Milk Production -- Drugs That Decrease Lactation -- Drugs That Increase Lactation (Galactogogues) -- Passage of Medications Into the Mother's Milk and Drug Transport -- Drug Milk-to-Plasma Ratio -- Drug Dose Received by the Infant (Level of Exposure) -- Amount of Medication in Milk and Relative Dose -- Exposure Index -- Relative Dose -- DRUG DISPOSITION IN THE INFANT -- Gastrointestinal Biotransformation and Transport in the Newborn and Infant -- Hepatic Biotransformation in the Fetus and Neonate -- Renal Excretion -- Immune System in Neonates -- Drug Passage Into the CNS -- DRUGS THAT SHOULD BE USED WITH CAUTION -- Analgesics -- Antibiotics -- Cardiovascular Drugs -- Steroidal Hormonal Drugs -- Antiepileptics -- Psychoactive Drugs -- Sedatives and Hypnotics -- Antidepressants -- Anticoagulants -- Antihypertensives -- Beta-Blockers -- Calcium Channel Blockers -- Methyldopa -- Angiotensin-Converting Enzyme Inhibitors -- Potential Improvement of Study of Antihypertensive Drugs in Breast-Feeding Women -- COMMONLY USED HERBAL PRODUCTS -- Food/Dietary Supplements -- NONMEDICINAL SUBSTANCES -- Recreational Drugs -- Opiates -- Stimulants -- Hallucinogens -- Alcohol -- "Sniffed" Substances -- ENVIRONMENTAL POLLUTANTS -- Persistent Organic Pollutants in Breast Milk
Content:
Poly and Perfluoroalkyl Substances -- Endocrine-Disrupting Compounds -- Bisphenol A -- Di-(2-ethylhexyl) phthalate -- Nonylphenols -- Heavy Metals -- CONCLUDING REMARKS AND FUTURE DIRECTIONS -- References -- II - TOXICITY TESTING MODELS AND SAFETY EVALUATION -- 6 - Reproductive and Developmental Safety Evaluation of New Pharmaceutical Compounds -- INTRODUCTION -- OVERVIEW OF HUMAN PHARMACEUTICAL DEVELOPMENT PROCESS -- Innovator Pharmaceuticals-Small Molecules or Biotherapeutics -- Generic Drug Approval for Small-Molecule Candidates -- Overview of History of Generic Drug Approval Process in the United States -- Biosimilar or Biobetter Drugs or Biotherapeutics -- DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES NEEDED FOR DEVELOPMENT OF INNOVATIVE HUMAN PHARMACEUTICALS -- Overview -- History and Evolution of Reproductive Testing Guidelines -- Outlines of Developmental and Reproductive Toxicity Studies (per ICH Guidelines) -- Description of Existing Guidelines -- ICH Stages -- General Considerations Defined by ICH S5 (R2) -- Consideration for Performing DART Studies for Biotherapeutics -- Timing of DART Studies During Drug Development Process -- Options to Improve Detection and Interpretation of Reproductive Hazards -- INTERPRETATION OF HUMAN RISK FROM THE REPRODUCTIVE AND DEVELOPMENTAL TOXICITY STUDIES IN ANIMALS -- Overview -- Current FDA Approach for Human Reproductive Risk Assessment When Only Animal Data Are Available -- Predictive Value of Animal DART Studies for Effects in Humans -- REPRODUCTIVE RISKS COMMUNICATION AND MANAGEMENT -- Product Label as an Effective Communication Tool -- Management of Reproductive Risks After Drug Approval -- CONCLUDING REMARKS AND FUTURE DIRECTIONS -- Development and Validation of New DART Tests Using Emerging Technologies -- Modern Imaging Procedures for Morphological Examination of Fetuses -- References
Content:
7 - Juvenile Toxicology Testing -- INTRODUCTION -- CONSIDERATIONS REGARDING TOXICOLOGY STUDIES CONDUCTED FOR SUBMISSION TO REGULATORY AGENCIES -- Test Species-Selection and Numbers -- Microsampling Techniques for Bioanalytical Analysis -- Historical Control Data -- Proper Dosage Selection-The Value of Dosage-Range Studies -- Selection of the Proper Model -- Route and Method of Administration -- Gavage -- Intravenous -- Infusion -- Subcutaneous or Intramuscular -- Dermal -- Inhalation -- Distribution of Animals to Dosage Groups -- Preweaning Dosing -- Postweaning Dosing -- ANATOMICAL AND FUNCTIONAL ASSESSMENTS -- Body Weight and Food Consumption -- Crown-Rump Length -- Bone Measurements -- Clinical Pathology -- Physical Landmarks -- Sexual Maturation -- Behavioral Evaluations -- Motor Activity -- Auditory Startle Response -- Learning and Memory -- Water Maze -- Passive or Active Avoidance -- Functional Observational Battery -- Behavioral Testing in Larger Animals -- Eye Blink -- Behavioral Testing in Pigs -- Reproduction -- Evaluation of Estrous Cycling -- Evaluation of Mating Behavior and Fertilization -- Sperm Collection -- Cesarean-Sectioning Procedures and Fetal Evaluations -- Immunotoxicity -- Postmortem Analyses -- CONCLUDING REMARKS AND FUTURE DIRECTIONS -- References -- 8 - Postmarket Surveillance and Regulatory Considerations in Reproductive and Developmental Toxicology: A Food and ... -- INTRODUCTION -- Brief History of the Food and Drug Administration -- Overview of the FDA's Postmarket Surveillance and Pharmacovigilance -- DRUGS INTENDED FOR USE IN HUMANS -- VACCINES INTENDED FOR USE IN HUMANS -- DRUGS INTENDED FOR USE IN ANIMALS -- Disclaimer -- References -- 9 - OECD Guidelines for In Vivo Testing of Reproductive Toxicity -- INTRODUCTION -- PRENATAL DEVELOPMENTAL TOXICITY STUDY (OECD 414) -- Uterine Contents -- Examination of Fetuses
Content:
Data and Reporting
Additional Edition:
ISBN 9780123820327
Additional Edition:
ISBN 9780123820334
Additional Edition:
ISBN 9780128042397
Additional Edition:
Print version Gupta, Ramesh C Reproductive and Developmental Toxicology Saint Louis : Elsevier Science,c2017 ISBN 9780128042397
Language:
English
URL:
Volltext
(lizenzpflichtig)
Bookmarklink
