Composite Plot for Visualizing Aminotransferase and Bilirubin Changes in Clinical Trials of Subjects with Abnormal Baseline Values.

Introduction: On-treatment excursions of liver laboratory test values in clinical trials involving subjects with underlying liver disease are relevant for the efficacy and safety assessment of drug products and biologics. Existing visualization and analysis tools do not efficiently provide an integrated view of these excursions when baseline liver tests are abnormal.

Objective: The aim of this study was to develop a composite plot that enables visualization of on-treatment changes in liver test results both as multiples of the upper limit of normal defined by each laboratory's reference population (×ULN) and multiples of the subjects' baseline (×BLN) values.

Informatics in Medical Product Regulation: The Right Drug at the Right Dose for the Right Patient.

This chapter describes the role of regulatory medical product review in furthering precision medicine. Efficient data processing and appropriate analyses are needed to synthesize information and provide directions for use in a medical product label. We describe opportunities and challenges in outcome assessment through informatics, as bioengineered therapeutics are increasingly developed for the unmet needs of molecularly defined diseases.