The Path from Biomarker Discovery to Regulatory Qualification, 1st Edition

  • Published By:
  • ISBN-10: 0123944082
  • ISBN-13: 9780123944085
  • DDC: 610.28
  • Grade Level Range: College Freshman - College Senior
  • 206 Pages | eBook
  • Original Copyright 2013 | Published/Released June 2014
  • This publication's content originally published in print form: 2013

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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.

Table of Contents

Front Cover.
Half Title Page.
Title Page.
Copyright Page.
1: Introduction.
2: Biomarker Applications in the Pharmaceutical Industry.
3: Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development.
4: Regulatory Experience of Biomarker Qualification in the EMA.
5: Regulatory Experience at the FDA, EMA, and PMDA: Regulatory Experience at the PMDA.
6: Biomarker Development and Qualification in the Pharmaceutical Industry.
7: The Impact of Changing Context of Use on Weight of Evidence for Qualification of Biomarkers: A Case Study in Ischemic Stroke.
8: Safety Biomarker Development and Qualification in the Pharmaceutical Industry.
9: First-Ever Regulatory Biomarker Qualification – Review and Insights by a Participant.
10: Metabolomics-Derived Biomarkers of Drug-Induced Skeletal Muscle Injury and Urinary Bladder Transitional Cell Carcinoma in Rats.
11: Molecular Biomarkers for Patients with Castration-Resistant Prostate Cancer: Validating Assays Predictive of Tumor Response.
12: Toxicogenomic Biomarkers.
13: Gene Logic and Toxicogenomics Biomarkers.
14: The When, Where and How of Toxicogenomic Submissions to Regulatory Agencies: The Deliberations of the HL7/CDISC/I3C Pharmacogenomics Data Standards Track 1 Toxicogenomics Working Group.
15: Biomarker Qualification – Past, Present and Future: Initiating a Cross-Sector Toxicogenomics Biomarker Initiative – Health and Environmental Sciences Institute (HESI) Committee on Application of Genomics to Mechanism-Based Risk Assessment.
16: Biomarkers of Drug Safety.
17: ‘Classic’ Biomarkers of Liver Injury.
18: Qualification of Urinary Biomarkers for Kidney Toxicity.
19: Consortia.
20: Renal Biomarker Qualification: An ILSI Health and Environmental Sciences Institute Perspective.
21: Vignette Regarding Consortia: C-Path Institute.
22: The Telemetric and Holter ECG Warehouse to Enable the Validation and Development of Novel Electrocardiographic Markers.
23: Path to Regulatory Qualification Process Development.
24: Path to Regulatory Qualification Program Development: A US FDA Perspective.
25: Path to Regulatory Qualification Process Development.
26: The Tortuous Path From Development to Qualification of Biomarkers.