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Pedal : identification of models for duodenal administration of levodopa
Högskolan Dalarna, Akademin Industri och samhälle, Datateknik.ORCID-id: 0000-0003-0403-338X
Högskolan Dalarna, Akademin Industri och samhälle, Datateknik.
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2006 (Engelska)Ingår i: European Journal of Neurology, Glasgow, UK, 2006, Vol. 13, s. 220-21Konferensbidrag, Publicerat paper (Refereegranskat)
Abstract [en]

Backgound and aims: The main purpose of the PEDAL study is to identify and estimate sample individual pharmacokinetic- pharmacodynamic (PK/PD) models for duodenal infusion of levodopa/carbidopa (Duodopa®) that can be used for in numero simulation of treatment strategies. Other objectives are to study the absorption of Duodopa® and to form a basis for power calculation for a future larger study. PK/PD based on oral levodopa is problematic because of irregular gastric emptying. Preliminary work with data from [Gundert-Remy U et al. Eur J Clin Pharmacol 1983;25:69-72] suggested that levodopa infusion pharmacokinetics can be described by a two-compartment model. Background research led to a hypothesis for an effect model incorporating concentration-unrelated fluctuations, more complex than standard E-max models. Methods: PEDAL involved a few patients already on Duodopa®. A bolus dose (normal morning dose plus 50%) was given after a washout during night. Data collection continued until the clinical effect was back at baseline. The procedure was repeated on two non-consecutive days per patient. The following data were collected in 5 to 15 minutes intervals: i) Accelerometer data. ii) Three e-diary questions about ability to walk, feelings of “off” and “dyskinesia”. iii) Clinical assessment of motor function by a physician. iv) Plasma concentrations of levodopa, carbidopa and the metabolite 3-O-methyldopa. The main effect variable will be the clinical assessment. Results: At date of abstract submission, lab analyses were currently being performed. Modelling results, simulation experiments and conclusions will be presented in our poster.

Ort, förlag, år, upplaga, sidor
Glasgow, UK, 2006. Vol. 13, s. 220-21
Nyckelord [en]
Pharmacokinetic, pharmacodynamic, dose response model, simulation, identification, estimation, clinical study, Parkinson, Duodopa, levodopa infusion
Identifikatorer
URN: urn:nbn:se:du-1918OAI: oai:dalea.du.se:1918DiVA, id: diva2:521578
Konferens
10th Congress of the European Federation of Neurological Societies , Glasgow, UK, Sept 2-5, 2006
Tillgänglig från: 2006-03-07 Skapad: 2006-03-07 Senast uppdaterad: 2015-06-01Bibliografiskt granskad

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