Teratogenicity testing: methods and protocols / ed. by P.C.Barrow. - New York: Humana Press, 2013. - xiv, 601 p.: ill. (Methods in molecular biology; 947) (Springer protocols). - Incl. bibl. ref. - Ind.: p.587-601. - ISBN 978-1-62703-130-1; ISSN 1064-3745  Место хранения:   056 | Институт химической биологии и фундаментальной медицины CO РАН | Новосибирск| Библиотека

Оглавление / Contents

Preface ....................................................... vii Contributors ................................................. xiii 1 The ICH S5(R2) Guideline for the Testing of Medicinal Agents ....................................................... 1 L. David Wise 2 Nonclinical Reproductive Toxicity Testing Requirements for Drugs, Pesticides, and Industrial Chemicals in India and China ....................................................... 13 K.S. Rao and Jing Dong 3 The Developmental Toxicity Testing of Biologies ............. 31 Keith P. Hazelden 4 The OECD Guidelines for the Testing of Chemicals and Pesticides .................................................. 37 Jochen Buschmann 5 Teratology Testing Under REACH .............................. 57 Steve Barton 6 The Teratology Testing of Food Additives .................... 73 Paul C. Barrow and Francois Spezia 7 Developmental Toxicity Testing of Vaccines .................. 81 Paul C. Barrow and Linda Allais 8 The Teratology Testing of Cosmetics ......................... 91 François Spézia and Paul C. Barrow 9 Teratology Studies in the Rat ............................... 95 Mariline Leroy and Linda Allais 10 Teratology Studies in the Mouse ............................ 111 Edward Marsden and Mariline Leroy 11 Combined Fertility and Embryotoxicity Study ................ 125 Lucie Reynaud and Edward Marsden 12 Teratology Studies in the Rabbit ........................... 139 Linda Allais and Lucie Reynaud 13 Teratology Studies in the Minipig .......................... 157 Peter A. McAnulty 14 Embryo fetal Development Studies in Nonhuman Primates ...... 169 Antje Fuchs, Eberhard Buse, and Gerhard F. Weinbauer 15 The Enhanced Pre- and Postnatal Development Study for Monoclonal Antibodies ...................................... 185 Gerhard F. Weinbauer, Joerg Luft, and Antje Fuchs 16 Skeletal Examination by Alizarin Staining .................. 201 Lucie Reynaud and Audrey Jocteur-Monrozier 17 Skeletal Examination by Double Staining for Ossified Bone and Cartilaginous Tissue ................................... 215 Steffen Schneider 18 Small Animal Imaging and Examination by Micro-CT ........... 223 Sergio X. Vasquez, Neha Shah, and Alan M. Hoberman 19 Fetal Soft Tissue Examination by Serial Sectioning ......... 233 Karon Critchell 20 Fetal Soft Tissue Examinations by Microdissection .......... 243 Mariline Leroy and Audrey Jocteur-Monrozier 21 Soft Tissue Examination of the Fetal Rat and Rabbit Head by Magnetic Resonance Imaging .............................. 255 Julian M. French and Neil Woodhouse 22 Historical Control Data in Reproductive and Developmental Toxicity Studies ........................................... 275 Eve Mylchreest and Stephen B. Harris 23 Reporting of Teratology Studies ............................ 295 Paul C. Barrow and Lucie Reynaud 24 Maternal Toxicity .......................................... 311 Bengt R. Danielsson 25 Innovations in Testing Strategies in Reproductive Toxicology ................................................. 327 Aldert H. Piersma 26 Predictive Models and Computational Toxicology ............. 343 Thomas Knudsen, Matthew Martin, Kelly Chandler, Nicole Kleinstreuer, Richard Judson, and Nisha Sipes 27 The Embryonic Stem Cell Test ............................... 375 Sjors H. W. Schulpen and Aldert H. Piersma 28 Zebrafish Teratogenicity Testing ........................... 383 Kimberly C. Brannen, Jeffrey H. Charlap, and Elise M. Lewis 29 Frog Embryo Teratogenesis Assay on Xenopus and Predictivity Compared with In Vivo Mammalian Studies ....... 403 Isabelle Leconte and Isabelle Mouche 30 The Rat Whole Embryo Culture Assay Using the Dysmorphology Score System ................................. 423 Cindy Zhang, Julie Panzica-Kelly, and Karen Augustine- Rauch 31 Toxicogenomic Approaches in Developmental Toxicology Testing .................................................... 451 Joshua F. Robinson and Aldert H. Piersma 32 Validation of Alternative Tests for Developmental and Reproductive Toxicology Testing: An ILSI Health and Environmental Sciences Institute Perspective ............... 475 James H. Kim 33 Regulatory Assessment of Reproductive Toxicology Data ...... 489 Elizabeth Davidson 34 Hazard and Risk Assessment of Teratogenic Chemicals Under REACH ...................................................... 517 Wiebke Prutner 35 Reproductive Toxicity Risk Assessment for Pesticides ....... 545 Beate Ulbrich 36 The Thalidomide Disaster, Lessons from the Past ............ 575 James E. Ridings Index ......................................................... 587