Analytical Method Validation for Biomarkers As a Drug Development Tool: Points to Consider
Authors:
- 14 September 2021
- journal article
- research article
- Published by Taylor & Francis in Bioanalysis
- Vol. 13 (18) , 1379-1389
Abstract
Biomarkers are an important drug developmental tool. Assessment of quantitative analytical methods of biomarkers is not included in any regulatory documents in Japan. Use of biomarkers in clinical ...Keywords
Funding Information
- Research of Regulatory Sciences on Drugs and Others, and Development of New Drugs, Japan Agency for Medical Research and Development
This publication has 5 references indexed in Scilit:
- Biomarker Assay Validation for Clinical Trials: a Questionnaire Survey to Pharmaceutical Companies in JapanBioanalysis, 2018
- Workshop Report: Crystal City VI—Bioanalytical Method Validation for BiomarkersThe AAPS Journal, 2016
- Recommendations on Biomarker Bioanalytical Method Validation By GccBioanalysis, 2012
- European Bioanalysis Forum Recommendation on Method Establishment And Bioanalysis of Biomarkers in Support of Drug DevelopmentBioanalysis, 2012
- Fit-for-Purpose Method Development and Validation for Successful Biomarker MeasurementPharmaceutical Research, 2006