Forschungs- & Entwicklungsinformationsdienst der Gemeinschaft - CORDIS

Pharmacokinetic / Pharmacodynamic Drug Information and Dosage Adjustment System PharmDIS

Objectives:
-Not only every patient is different, but also every drug. Drug dosage must be individualised, and adjusted to the patient's organ function and severity of disease. Recording of the published pharmacokinetic parameters in a structured format contributes an essential component for an operational and rule-based dosage adjustment system.

Methods:
-The required components are available, namely the pharmacokinetic /-dynamic database, calculation algorithms, a graphical user interface, a general pharmacokinetic concept, dose adjustment rules, and the standard nomenclature to be used (ATC code). Standard doses and available drug formulations have to be added to the actual database in order to derive practically applicable dosage proposals. The developed components will be validated technically, and statistically certified by plausibility and consistency testing based on formulas that can be derived from the close correlation between pharmacokinetic parameters, such as (Cl = 0.693 ? Vd / T½). Tools will be developed for data import (laboratory values) and structured text analysis for maintenance of the database.

Results:
-At present information is recorded for 2,496 generic drugs (acyclovir, zidovudine) as extracted from 4,318 primary scientific citations (NEJM, Drugs ). NEPharm provides 37 slots for pharmacokinetic and pharmacodynamic parameters as well as different clinical categories (e.g. T½, CE50, Neonatal). Based on 29,945 extracted values a statistically synthesised estimate is calculated for 13,824 pharmacokinetic and pharmacodynamic parameters. In addition, categories are provided for drug interactions (e.g. cyclosporin-rifampicin), and fast/slow metabolism, or other polymorphism's (P-glycoprotein transporter).

Conclusion:
-PharmacoKinetic, PharmacoDynamic and PharmacoGenetic knowledge may be recorded in discrete or dichotomous categories. Where such functions are known, as for example in renal impairment, individual parameters can be estimated by rule-based interpolation.

Reported by

University of Ulm
Robert Koch Strasse 8
89070 Ulm
Germany
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