With the emphasis on biomarkers to improve drug development the question arises as how to interpret the data.
The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range) and from this range defining the probably of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.
The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approached based embracing biological variation will be proposed.
Biomarker Data Interpretation and Challenges of Biological Variation is being presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, Covance Central Laboratory Services and airs Wednesday, January 28th 2009. For more details or to register for this audio conference, please visit our site www.fxconferences.com
