LEADER 04909nam 22005415 450 001 9910253895003321 005 20230907124804.0 010 $a3-319-33826-9 024 7 $a10.1007/978-3-319-33826-2 035 $a(CKB)3710000000873117 035 $a(DE-He213)978-3-319-33826-2 035 $a(MiAaPQ)EBC4697485 035 $a(PPN)195507665 035 $a(EXLCZ)993710000000873117 100 $a20160926d2016 u| 0 101 0 $aeng 135 $aurnn#008mamaa 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aValidation of Alternative Methods for Toxicity Testing /$fedited by Chantra Eskes, Maurice Whelan 205 $a1st ed. 2016. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2016. 215 $a1 online resource (XX, 407 p. 44 illus., 40 illus. in color.) 225 1 $aAdvances in Experimental Medicine and Biology,$x0065-2598 ;$v856 311 08$aPrint version: Validation of alternative methods for toxicity testing. [Cham, Switzerland] : Springer, c2016 xx, 407 pages Advances in experimental medicine and biology ; Volume 856. 9783319338248 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aIntroduction -- Validation in support of internationally harmonised OECD Test Guidelines for assessing the safety of chemicals -- Regulatory acceptance of alternative methods in the development and approval of pharmaceuticals -- Validation of alternative in vitro methods to animal testing: concepts, challenges, processes and tools -- Practical aspects of designing and conducting validation studies involving multi-study trials -- Validation of computational methods -- Implementation of New Test Methods into Practical Testing -- Pathway Based Toxicology and Fit-for-Purpose Assays -- Evidence-based toxicology -- Validation of transcriptomics-based in vitro methods -- Ensuring the quality of stem cell-derived in vitro models for toxicity testing -- Validation of bioreactor and human-on-a-chip devices for chemical safety assessment -- Integrated approaches to testing and assessment -- International harmonization and cooperation in the validation of alternative methods -- Evolving the principles and practice of validation for new alternative approaches to toxicity testing. . 330 $aThis book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing. . 410 0$aAdvances in Experimental Medicine and Biology,$x0065-2598 ;$v856 606 $aPharmaceutical technology 606 $aMolecular biology 606 $aPharmaceutical Sciences/Technology$3https://scigraph.springernature.com/ontologies/product-market-codes/B21010 606 $aMolecular Medicine$3https://scigraph.springernature.com/ontologies/product-market-codes/B1700X 615 0$aPharmaceutical technology. 615 0$aMolecular biology. 615 14$aPharmaceutical Sciences/Technology. 615 24$aMolecular Medicine. 676 $a615.704028 702 $aEskes$b Chantra$4edt$4http://id.loc.gov/vocabulary/relators/edt 702 $aWhelan$b Maurice$4edt$4http://id.loc.gov/vocabulary/relators/edt 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910253895003321 996 $aValidation of Alternative Methods for Toxicity Testing$92527120 997 $aUNINA