Best Practices in Preclinical Biomarker Sample Collections

BEST PRACTICES IN PRECLINICAL BIOMARKER SAMPLE COLLECTIONS 

Development Sciences-Safety Assessment, Genentech Inc., South San Francisco, CA, USA 

1 CONSIDERATIONS FOR REDUCING PREANALYTICAL VARIABILITY IN BIOMARKER TESTING 

Careful understauding of the effects of each preanalytical variable on the biomarker data is complex and necessitates a staged approach conceptually similar to the fit-for-purpose analytical validation of a biomarker assay (see Chapter 41). In the early exploratory phase of biomarker investigation, standardization of procedures with a defined protocol for sample collection and handling will permit comparative interpretation and analysis of the data within study and/or between studies. Minimally, variables that should be experimentally evaluated to optimize sample collection for a specific biomarker will include matrix type, preservation 

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