"The Path from Biomarker Discovery to Regulatory Qualification "is a unique guide that focuses on biomarker qualification, its history and current regulatory settings in both the US and abroad. This multi-contributed book provides a detailed look at the next step to developing biomarkers for clinical use and covers overall concepts, challenges, strategies and solutions based on the experiences of regulatory authorities and scientists. Members of the regulatory, pharmaceutical and biomarker development communities will benefit the most from using this book-it is a complete and practical guide to biomarker qualification, providing valuable insight to an ever-evolving and important area of regulatory science.

For complimentary access to chapter 13, "'""Classic' Biomarkers of Liver Injury, " by John R. Senior, Associate Director for Science, Food and Drug Administration, Silver Spring, Maryland, USA, please visit the following site: http: //tinyurl.com/ClassicBiomarkers
Contains a collection of experiences of different groups taking different types of biomarkers to different levels of qualification and provides insightful case studies of an important area of regulatory science

Focuses on practical advice, concepts, strategies and overall outcomes to support those working toward biomarker qualification for clinical use

Offers a valuable resource for members of the regulatory, pharmaceutical and biomarker development communities. "

Volume 14 in the series "Comprehensive Toxicology" extends and complements the previously published 13-volume set. This volume will be available separately.

Toxicology is the study of the nature and actions of chemicals on biological systems. In more primitive times, it really was the study of poisons. However, in the early 1500s, it was apparent to Paracelsus that "the dose differentiates a poison and a remedy." Clearly, the two most important tenets of toxicology were established during that time. The level of exposure (dose) and the duration of exposure (time) will determine the degree and nature of a toxicological response.

Since that time the discipline of toxicology has made major advances in identifying and characterizing toxicants. The growth of toxicology as a scientific discipline has been driven to a large extent by the use of extremely powerful molecular and cell biology techniques. The overall aim of this volume is to demonstrate how these advances are being used to elucidate causal pathways (or linkages) for potential adverse health consequences of human exposure to environmental chemicals or radiation.

A unique feature of this volume is its illustration of how carefully-designed studies of the molecular mechanisms of chemical action provide not only understanding of the potential toxicity of the chemical under investigation, but also new insights into the functioning of the biological system used as an experimental model. Each chapter contains a listing of major peer-reviewed articles and reviews and useful web-sites. In addition, each chapter contains a broad introductory section that outlines the subsequent sections. These Introductory and Overview sections are designed to be stand alone chapters, and may be packaged as a textbook in graduate level courses.

The field of toxicogenomics is moving rapidly, so it is impossible at the timeofthiswritingtocompileaclassicmethodstextbook.Instead,wechose to identify experts in all aspects of this field and challenged them to write reviews, opinion pieces, and case studies. This book covers the main areas important to the study and use of toxicogenomics. Chapter 1 speaks to the convergenceofclassicapproachesalongsidetoxicogenomics.Chapter2deals withtheusefulnessoftoxicogenomicstoidentifythemechanismoftoxicity. Chapter3callsattentiontotheissuesthataffectthequalityoftoxicogenomics experiments, as well as the implications of using microarrays as diagnostic devices. The need for appropriate statistical approaches to genomic data is discussed in Chapter 4, and Chapters 5 and 6 describe the use of genomic datatobuildtoxicogenomicmodelsandprovideinsightsfromtheapproaches oftwocompanies.Theimportanttopicofstoringthedatageneratedinsuch experiments and the correct annotation that must accompany such data is considered in Chapter 7. The discussion in Chapter 8 speaks to the use of toxicogenomicstoidentifyspeciessimilaritiesanddifferences.Chapters9and 10dealwiththeuseofgenomicstoidentifybiomarkerswithinthepreclinical andclinicalarenas. Biomarkerswillonlybeusefulifthecommunityatlarge acceptsthemasmeaningful.Consortiaareimportanttodrivethisfunction,and Chapter11discussescurrenteffortsinthisarea.Lastbutnotleast,Chapter12 presentsaperspectiveontheregulatoryimplicationsoftoxicogenomicdataand someofthehurdlesthatcanbeseeninitsimplicationinGLPstudies.Although thisbooktendstofocusonpharmaceuticals,theissuesfacingtoxicologyare sharedbythechemicalmanufacturers,thetobaccoindustry,andtheirregulators. We want to thank our contributors for their generous time and energy in providingtheirinsights.Sadly,wemustnotetheunexpectedpassingofone ofourauthors,Dr.JosephHackettoftheFDA.Joe'scontributionservesasa testimonytohisaccomplishmentsinthisfield,andhisinsightwillbemissed intheyearstocome.

The field of toxicogenomics is moving rapidly, so it is impossible at the timeofthiswritingtocompileaclassicmethodstextbook.Instead, wechose to identify experts in all aspects of this field and challenged them to write reviews, opinion pieces, and case studies. This book covers the main areas important to the study and use of toxicogenomics. Chapter 1 speaks to the convergenceofclassicapproachesalongsidetoxicogenomics.Chapter2deals withtheusefulnessoftoxicogenomicstoidentifythemechanismoftoxicity. Chapter3callsattentiontotheissuesthataffectthequalityoftoxicogenomics experiments, as well as the implications of using microarrays as diagnostic devices. The need for appropriate statistical approaches to genomic data is discussed in Chapter 4, and Chapters 5 and 6 describe the use of genomic datatobuildtoxicogenomicmodelsandprovideinsightsfromtheapproaches oftwocompanies.Theimportanttopicofstoringthedatageneratedinsuch experiments and the correct annotation that must accompany such data is considered in Chapter 7. The discussion in Chapter 8 speaks to the use of toxicogenomicstoidentifyspeciessimilaritiesanddifferences.Chapters9and 10dealwiththeuseofgenomicstoidentifybiomarkerswithinthepreclinical andclinicalarenas.Biomarkerswillonlybeusefulifthecommunityatlarge acceptsthemasmeaningful.Consortiaareimportanttodrivethisfunction, and Chapter11discussescurrenteffortsinthisarea.Lastbutnotleast, Chapter12 presentsaperspectiveontheregulatoryimplicationsoftoxicogenomicdataand someofthehurdlesthatcanbeseeninitsimplicationinGLPstudies.Although thisbooktendstofocusonpharmaceuticals, theissuesfacingtoxicologyare sharedbythechemicalmanufacturers, thetobaccoindustry, andtheirregulators. We want to thank our contributors for their generous time and energy in providingtheirinsights.Sadly, wemustnotetheunexpectedpassingofone ofourauthors, Dr.JosephHackettoftheFDA.Joe'scontributionservesasa testimonytohisaccomplishmentsinthisfield, andhisinsightwillbemissed intheyearstoc