Contraceptive Steroids
Kluwer Academic / Plenum Publishers (Verlag)
978-0-306-42393-2 (ISBN)
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In April 1983, the Food and Drug Administration and the National Insti- tutes of Health in cooperation with the World Health Organization, the Population Council, and the Agency for International Development sponsored a three-day workshop to evaluate current guidelines for preclinical safety studies of contraceptive drugs in light of our extensive knowledge of the side effects of marketed products. The meeting included presenta- tions by experts in the fields of comparative metabolism, pharmacokinetics, pharmacology, carcinogenicity, toxicology, coagulation, lipid metabolism, epidemiology and pathology at a meeting of the Fertility and Maternal Health Drugs Advisory Committee of the National Center for Drugs and Biologics, Food and Drug Administration.
Opening Remarks.- Oral Contraceptives and the Occurrence of Disease: Clinical Overview.- Section I Comparative Metabolism, Pharmacokinetics and Pharmacology Steroid Contraceptives.- The Role of Pharmacokinetics in Preclinical Safety Studies of Synthetic Sex Steroids.- Pharmacokinetics of Contraceptive Steroids in Humans.- Species Differences in Metabolism of Contraceptive Steroids.- Steroids of One Class Can Mimic, Inhibit and Potentiate the Biological Effects of Other Steroid Classes when Administered at High Doses.- Mechanism of Action of Estrogen and its Relationship to Toxicological Assessment.- Endocrine Effects of Systemic Steroidal Contraceptives.- Hepatotoxicity of Oral Contraceptives.- New Steroidal Contraceptives, Implications for Toxicological Models.- Summary.- Section II Contraceptive Steroids and Carcinogenicity.- Steroids and Carcinogenesis.- An Assessment of the Toxicological and Carcinogenic Hazards of Contraceptive Steroids.- Estrogens and Carcinogenicity: An Overview of Information from Studies in Experimental Animal Systems.- A Twenty Year Summary of FDA Animal Safety Testing of Contraceptive Steroids.- Section III Effects of Contraceptive Steroids on Coagulation and Lipid Metabolism.- Contraceptive Steroids and Thrombosis.- The Effects of Oral Contraceptive Use on Lipoproteins: Significance for Atherosclerosis.- Cynomolgus Macaques as Models for Evaluating Effects of Contraceptive Steroids on Plasma Lipoproteins and Coronary Artery Atherosclerosis.- Contraceptive Steroid Effects on Serum Lipoproteins and Lipoprotein Subclasses.- Section IV Panel of International Drug Regulatory Agencies.- Panel of International Drug Regulatory Agencies.- Section V Discussion and Advisory Committee Recommendations.- Discussion and Recommendations.- Organizing Committee.
Erscheint lt. Verlag | 31.10.1986 |
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Zusatzinfo | 56 black & white illustrations, biography |
Verlagsort | Dordrecht |
Sprache | englisch |
Gewicht | 910 g |
Themenwelt | Medizin / Pharmazie ► Medizinische Fachgebiete ► Gynäkologie / Geburtshilfe |
Medizin / Pharmazie ► Pharmazie | |
ISBN-10 | 0-306-42393-6 / 0306423936 |
ISBN-13 | 978-0-306-42393-2 / 9780306423932 |
Zustand | Neuware |
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