HIV Pharmacology Data Repository: Setting the New Information-Sharing Standard for Clinical and Preclinical Pharmacokinetic Studies.

Drug development approaches increasingly harness computational modeling to predict drug behavior. These in silico approaches, collectively termed "pharmacometrics", have significant value in deriving biological meaning from the analysis of pooled drug concentration vs. time (CvT) datasets. However, the field lacks standardization for pharmacokinetic data description, requiring expert annotation to enable aggregate mining and sharing. These limitations impede data sharing and preservation as mandated by current NIH policies. To this end, we propose a minimum information standard for pharmacokinetic studies composed of three categories (Intervention, System, and Concentration). We implement this standard in the development of a web-based database: the HIV Pharmacology Data Repository (HIV PDR). We describe our technical approach for creating the HIV PDR, the protocols we established for standardized data deposition, and the current content of the database. We also demonstrate the utility of the HIV PDR for pharmacometrics research through computational modeling of CvT data extracted from this new database. Based on these efforts, we propose the HIV PDR as a standard to preserve and share pharmacokinetic data generated through preclinical and clinical HIV research.