ABSTRACT

Real-Time Clinical Trials.................................................................252 15.4 Transitioning the Clinical Pharmacogenomic Laboratory into a

Regulatory Compliant Environment ............................................................253 15.5 Assurance of Data Integrity Generated in Clinical Pharmacogenomic

Studies: Establishing Validated Databases and Data Transfers ..................255 15.6 Regulatory Considerations and Trial Design Issues during

Pharmacogenomic Marker Development.....................................................258 15.7 Summary ......................................................................................................261 References..............................................................................................................261