Original Publication Date: 1 June, 2018
Publication / Source: Bioanalysis 10(12)
Authors: Allinson JL
Biomarker assays have brought significant challenges to bioanalytical laboratories that historically have provided pharmacokinetic analytical services to the drug development industry. This has largely been due to two reasons: the lack of regulatory guidance in how to validate biomarker assays and the lack of scientists in bioanalytical laboratories with experience in this clinical arena. Since biomarkers have been measured for many decades in clinical laboratories globally,
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