Drug Development Tool

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

Preclinical biomarker qualification

Published by the Society for Experimental Biology and Medicine

Research and Drug DevelopmentBiomarkerDrug Development ToolQualification BiomarkerRegulatory QualificationPreclinical

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

FDA Qualification process – Drug Development Tools

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and Research

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