02977nam 2200589 a 450 991014101480332120200520144314.00-470-92272-91-283-07223-897866130722380-470-90991-90-470-90990-0(CKB)2670000000077520(EBL)675049(OCoLC)729724611(SSID)ssj0000486499(PQKBManifestationID)11311190(PQKBTitleCode)TC0000486499(PQKBWorkID)10441936(PQKB)11188861(MiAaPQ)EBC675049(Au-PeEL)EBL675049(CaPaEBR)ebr10454749(CaONFJC)MIL307223(PPN)182413926(EXLCZ)99267000000007752020100507d2011 uy 0engur|n|---|||||txtccrPharmaceutical toxicology in practice[electronic resource] a guide for non-clinical development /edited by Alberto Lodola, Jeanne StadlerHoboken, N.J. John Wiley & Sonsc20111 online resource (268 p.)Description based upon print version of record.0-470-37137-4 Includes bibliographical references and index.The regulatory environment / Claudio Bernardi and Marco Brughera --Toxicological development : roles and responsibilities / Franck Chuzel and Bernard Ruty -- Contract research organizations / Maurice Cary -- Safety pharmacology / Claudio Arrigoni and Valeria Perego -- Formulations, impurities and toxicokinetics / Claude Charuel -- General toxicology / Alberto Lodola -- Genetic toxicology / Peggy Guzzie-Peck, Jennifer Sasaki, and Sandy Weiner -- Developmental and reproductive toxicology / Jeanne Stadler -- Data analysis, report writing and regulatory documentation / Monique Y. Wells -- Risk management / Alberto Lodola.This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in tDrugsToxicity testingDrugsToxicity testing.615/.7040724Lodola Alberto942115Stadler Jeanne942116MiAaPQMiAaPQMiAaPQBOOK9910141014803321Pharmaceutical toxicology in practice2125758UNINA