Abstract
A multitude of pharmacokinetics studies have been published. However, due to the lack of an open database, pharmacokinetics data, as well as the corresponding meta-information, have been difficult to access. We present PK-DB (https://pk-db.com), an open database for pharmacokinetics information from clinical trials. PK-DB provides curated information on (i) characteristics of studied patient cohorts and subjects (e.g. age, bodyweight, smoking status, genetic variants); (ii) applied interventions (e.g. dosing, substance, route of application); (iii) pharmacokinetic parameters (e.g. clearance, half-life, area under the curve) and (iv) measured pharmacokinetic time-courses. Key features are the representation of experimental errors, the normalization of measurement units, annotation of information to biological ontologies, calculation of pharmacokinetic parameters from concentration-time profiles, a workflow for collaborative data curation, strong validation rules on the data, computational access via a REST API as well as human access via a web interface. PK-DB enables meta-analysis based on data from multiple studies and data integration with computational models. A special focus lies on meta-data relevant for individualized and stratified computational modeling with methods like physiologically based pharmacokinetic (PBPK), pharmacokinetic/pharmacodynamic (PK/PD), or population pharmacokinetic (pop PK) modeling.
Highlights
The pharmacokinetics (PK) of drugs and medication, i.e. how the body after administration affects substances via absorption, distribution, metabolization, and elimination, are of great interest for medical research and drug development
PK-DB is an open web-accessible database storing comprehensive information on pharmacokinetics studies consisting of PK data, PK parameters, and associated meta-information
A special focus lies on meta-data for individualized and stratified computational modeling of pharmacokinetics with methods like physiologically based pharmacokinetic (PBPK), pharmacokinetic/pharmacodynamic (PK/PD) or population pharmacokinetic modeling
Summary
The pharmacokinetics (PK) of drugs and medication, i.e. how the body after administration affects substances via absorption, distribution, metabolization, and elimination, are of great interest for medical research and drug development. The main measures in the field are concentrationtime profiles and derived PK parameters from these timecourses like half-lifes or clearance rates. These measures strongly depend on the dosage and individual characteristics of the subject or group under investigation. Modern approaches go beyond classical population information by accounting for additional factors, for example, for genetic variants [3]. This meta-information on subjects in combination with the main measures are the basis for individualized and stratified approaches in drug treatment which will potentially pave the road towards both precision dosing and precision medicine
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