Predictive Toxicology
From Vision to Reality
(Sprache: Englisch)
Tailored to the needs of scientists developing drugs, chemicals, cosmetics and other products this one-stop reference for medicinal chemists covers all the latest developments in the field of predictive toxicology and its applications in safety...
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Klappentext zu „Predictive Toxicology “
Tailored to the needs of scientists developing drugs, chemicals, cosmetics and other products this one-stop reference for medicinal chemists covers all the latest developments in the field of predictive toxicology and its applications in safety assessment.With a keen emphasis on novel approaches, the topics have been tackled by selected expert scientists, who are familiar with the theoretical scientific background as well as with the practical application of current methods. Emerging technologies in toxicity assessment are introduced and evaluated in terms of their predictive power, with separate sections on computer predictions and simulation methods, novel in vitro systems including those employing stem cells, toxicogenomics and novel biomarkers. In each case, the most promising methods are discussed and compared to classical in vitro and in vivo toxicology assays. Finally, an outlook section discusses such forward-looking topics as immunotoxicology assessment and novel regulatory requirements.With its wealth of methodological knowledge and its critical evaluation of modern approaches, this is a valuable guide for toxicologists working in pharmaceutical development, as well as in safety assessment and the regulation of drugs and chemicals.
Inhaltsverzeichnis zu „Predictive Toxicology “
PrefaceINTRODUCTION TO PREDICTIVE TOXICOLOGY TOOLS AND METHODSComputational Tools and BioinformaticsOmics TechnologiesData Interpretation and Knowledge ManagementBiomarker DevelopmentAdvanced In Vitro Systems and Stem Cell ResearchImmunogenicityIntegration and ValidationResearch Initiative/CollaborationsConcluding RemarksIN SILICO TOXICOLOGY - CURRENT APPROACHES AND FUTURE PERSPECTIVES TO PREDICT TOXIC EFFECTS WITH COMPUTATIONAL TOOLSIntroductionPrediction of HazardPrediction of RiskThoughts on ValidationConclusions and OutlookIN SILICO APPROACHES: DATA MANAGEMENT - BIOINFORMATICSIntroductionExperimental Setup and Statistical PowerProperties of Different Omics DataStatistical MethodsPrediction and ClassificationCombining Different Omics Data and Biological InterpretationsData ManagementROLE OF MODELING AND SIMULATION IN TOXICOLOGY PREDICTIONIntroductionThe Need to Bring PK and PD in Predictive Models TogetherMethodological Aspects and ConceptsApplication During Lead OptimizationApplication During Clinical Candidate SelectionEntry-into-Human Preparation and Translational PK/PD ModelingJustification of Starting Dose, Calculatin of Safety Margins, and Support of Phase I Clinical Trial DesignOutlook and ConclusionsGENOMIC APPLICATIONS FOR ASSESSING TOXICITIES OF LIVER AND KIDNEY INJURYIntroductionToxicogenomic ApproachesSpecific Applications of ToxicogenomicsToxicogenomic Applications for the Better Understanding of HepatotoxicityToxicogenomic Profiling of NephrotoxicityLimitations of ToxicogenomicsConclusionsUSE OF TOXICOGENOMICS FOR MECHANISTIC CHARACTERIZATION OF HEPATOCARCINOGENS IN SHORTER TERM STUDIESIntroductionToxicogenomicsConclusions and OutlookDISCOVERY AND APPLICATION OF NOVEL BIOMARKERSIntroductionNovel RNA BiomarkersDNA as a BiomarkerNovel Biomarkers: Beyond Nucleotide-Based DiscoverySummary and OutlookPREDICTIVE TOXICOLOGY: GENETICS, GENOMICS, EPIGENETICS, AND NEXT-GENERATION SEQUENCING IN TOXICOLOGYIntroductionTechnological AdvancesApplications in
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ToxicologySummary and OutlookBIOMARKERS AS TOOLS FOR PREDICTIVE SAFETY ASSESSMENT: NOVEL MARKERS OF DRUG-INDUCED KIDNEY INJURYNeed and Search for Novel Biomarkers of Kidney InjuryUrinary Biomarkers of Drug-Induced Kidney InjuryGenomic BiomarkersQualification and Use of Novel Kidney Injury Biomarkers in Preclinical Safety AssessmentSummary and PerspectivesTHE USE OF RENAL CELL CULTURE FOR NEPHROTOXICITY INVESTIGATIONSIntroductionIn Vitro Renal ModelsStem CellsOptimal Cell Culture ConditionsIn Vitro Nephrotoxicity AssessmentOutlookTHE ZEBRAFISH MODEL IN TOXICOLOGYThe Need for a Physiologically Relevant Organ Model in Drug Toxicity TestingExtensive Knowledge about Genetics, Development, and Physiology of D. rerioStudies of Specific Organ Toxicities in Zebrafish Embryos and LarvaePREDICTIVE METHOD DEVELOPMENT: CHALLENGES FOR COSMETICS AND GENOTOXICITY AS A CASE STUDYIntroductionThe Toolbox of Predicitve MethodsGenotoxicity as a Case StudyThe Way Forward: Combining In Silico and In Vitro ToolsUSING PLURIPOTENT STEM CELLS AND THEIR PROGENY AS AN IN VITRO MODEL TO ASSESS (DEVELOPMENTAL) NEUROTOXICITYIntroductionNeurodevelopment In VivoMain Principle of In Vitro Test Systems to Model DNTRequirements of an In Vitro Test System for DNT/NTModeling of Disease and Toxicant-Induced DamageUsing Stem Cells to Assess (Developmental) NeurotoxicityLimitationsSTEM CELL-BASED METHODS FOR IDENTIFYING DEVELOPMENTAL TOXICITY POTENTIALIntroductionDevelopmental Toxicity Screening: Past and PresentPluripotent Stem CellsMetabolomicsStem Cell-Based In Vitro Screens for Developmental Toxicity TestingSummaryIMMUNOGENICITY OF PROTEIN THERAPEUTICS: RISK ASSESSMENT AND RISK MITIGATIONIntroductionThe Central Role of CD4+ T CellsGeneration of T-Cell EpitopesTolerance to Therapeutic DrugsTool Set for Immunogenicity Risk AssessmentImmunogenicity Risk MitigationThe Integrated Strategy of Risk MinimizationSummaryREGULATORY ASPECTSThe History of Medicines Regulations in BriefImpact on Drug Success of the Current ICH Nonclinical Testing ParadigmActions Taken for Increasing the Drug Development SuccessInnovative Drugs: Impact on Nonclinical Development StrategiesEnvisaging a Paradigm ChangeRegulatory Actions Needed to Shift the Animal-Based ParadigmIndex
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Autoren-Porträt
Friedlieb Pfannkuch graduated as a physician from the Free University of Berlin, Germany and is Professor at the University of Basel, Switzerland. He has more than 27 years of experience in non-clinical safety assessment for all phases of drug development. During his career he was head of experimental toxicology at Ciba-Geigy in Basel, head of the non-clinical safety section at Yamanouchi Europe in the Netherlands, responsible for non-clinical nutrition safety at Roche Vitamins, and from 2003 until his retirement in 2011 he was a senior scientist in the global non-clinical drug safety department of F. Hoffmann-La Roche in Basel. He has contributed to international pharmaceutical consortia, such as toxicity testing of alternatives to CFCs propellants - IPACT, the ILSI task force on Food Safety in Europe and to working groups of the International Conference on Harmonization - ICH. IN the period from 2004-2009 he as the responsible manager of the European Commission's Research Framework Program 6 Project InnoMed: "Predictive Toxicology - PredTox".Laura Suter-Dick graduated as a biologist from the University of Buenos Aires (Argentina) and subsequently received her PhD from the Free University of Berlin (Germany). She has nearly 20 years of experience within the pharmaceutical industry, mainly in the field of toxicology. During her career in the pharmaceutical industry she worked as a scientist in the reproductive toxicology at Sandoz in Basel. She specialized in molecular toxicology (toxicogenomics) and in vitro assays at F. Hoffmann- La Roche Ltd., where she led the mechanistic toxicology. She has recently been appointed Professor for Molecular Toxicology at the Life Sciences School of the University of Applied Sciences and Arts Northwestern Switzerland. She acts as an external expert in several scientific panels and is also a Board Member of ESTIV (European Society of Toxicology in vitro).
Bibliographische Angaben
- 2014, 432 Seiten, 25 farbige Abbildungen, 11 Schwarz-Weiß-Abbildungen, Maße: 17,7 x 24,6 cm, Gebunden, Englisch
- Herausgegeben: Friedlieb Pfannkuch, Laura Suter-Dick, Raimund Mannhold
- Verlag: Wiley-VCH
- ISBN-10: 3527336087
- ISBN-13: 9783527336081
- Erscheinungsdatum: 21.11.2014
Sprache:
Englisch
Pressezitat
"This book is a sensible investment and recommended as a "must read" for toxicologists and pharmacologists to get a thorough understanding of the major challenges currently faced in realizing the objective of protecting human health using predictive toxicology." ( BTS Newsletter , 1 March 2015)Kommentar zu "Predictive Toxicology"
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