Drug Development Tool

  1. Showing 3 results for:
  2. Drug Development Tool
All Subjects

Biomarker Validation

Published by Research Advocacy Network

BiomarkerBiomarker ValidationCancer DiseaseDrug Development ToolPreclinicalResearch and Drug Development

This is a review about biomarkers definition and the components of validity. It examines the methods by which biomarkers are validated and consider some examples of cancer biomarkers in use today. It concludes with information about situations where advocates might find this information useful.

View this resource Bookmark this resource

FDA Qualification process – Drug Development Tools

Published by IRDiRC

Animal ModelBiomarkerCenter for Drug Evaluation and ResearchClinical DevelopmentDrug Development ToolEndpointQualification ProcessRegulatory AffairsResearch and Drug Development

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

View this resource Bookmark this resource

Preclinical biomarker qualification

Published by the Society for Experimental Biology and Medicine

BiomarkerDrug Development ToolPreclinicalQualification BiomarkerRegulatory QualificationResearch and Drug Development

An overview of the biomarker qualification process that provides information on current evidentiary considerations. It also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process

View this resource Bookmark this resource