WAPPS – Web-based Application for a Population Pharmacokinetic Service

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Presentation transcript:

WAPPS – Web-based Application for a Population Pharmacokinetic Service Florence, November 4th, 2014 Convegno Triennale AICE Alfonso Iorio & Massimo Morfini

3 background concepts Pharmacokinetics (PK) as one of the tool to personalize the clinical management of hemophilia Cumbersome to patients and doctors Population PK (PPK) as a tool to overcome limitations of the standard approach Beyond level of expertise of most treaters WAPPS - “Actively” monitored service to overcome difficulties to full automation and provide added value to the raw estimation

Population pharmacokinetic Is it reliable, precise, accurate? 11 data points classic PK PEAK & TROUGH PRECISION, ACCURACY

Population pharmacokinetic

Population pharmacokinetic

Population pharmacokinetic

Population pharmacokinetic 11 data points classic PK PEAK & TROUGH PRECISION, ACCURACY

Outline -Phases The Development of the Web-based Application for the Population Pharmacokinetic Service – Hemophilia (WAPPS-Hemo) – Phase 1 The Implementation, User Testing and Validation of the Web-based Application for the Population Pharmacokinetic Service – Hemophilia (WAPPS-HEMO) – Phase 2 Not sequential -

WAPPS – Design, methods Network enterprise Model building Development and research Model building Literature data Manufacturer data Independent PI data Website building Users feed-back

Login page

Patient data entry page

Patient data entry page

Infusion data entry

Concentration-time data entry

Report validation page

Report list page

Report page

Contact us Hemophilia.mcmaster.ca www.wapps-hemo.org Tamara Navarro-Ruan <navarro@mcmaster.ca>

Backup slides

Patient 1 Peak, Cmax, Recovery Half-life AUC Trough CL 1.725 Half-life (h) 12.5 Concentration (%) Half-life Trough Time (hours)

Basic Pharmacokinetics MEASURED AUClast = measured until the last data point k = estimated on the last (sole) monotonic curve (Ct = C0 * e-kt) CALCULATED AUCinf = Calculated starting from AUClast and k Clearance = Dose / AUCinf Vd(ss) = Clearance/k MRT=Vd(ss)/Cl T1/2= 0.693/k

Basic Pharmacokinetics AUC (IU*h dL-1) Recovery(IVR) (IU dL-1 per IU kg-1) Cmax (IU dL-1) MRT (h) Vd(ss) (dL kg-1) CL (dL kg-1 h-1) IVR = (Cmax (IU dL-1) –Cpre-inf (IU dL-1)/ Dadmin (IU kg-1)