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Publication Metadata only Statistical power calculations for mixed pharmacokinetic study designs using a population approach(2014-01-01) Frank Kloprogge; Julie A. Simpson; Nicholas P.J. Day; Nicholas J. White; Joel Tarning; Mahidol University; Nuffield Department of Clinical Medicine; University of MelbourneSimultaneous modelling of dense and sparse pharmacokinetic data is possible with a population approach. To determine the number of individuals required to detect the effect of a covariate, simulation-based power calculation methodologies can... be employed. The Monte Carlo Mapped Power method (a simulation-based power calculation methodology using the likelihood ratio test) was extended in the current study to perform sample size calculations for mixed pharmacokinetic studies (i.e. both sparsePublication Metadata only Pharmacokinetic properties of intramuscular versus oral syrup paracetamol in Plasmodium falciparum malaria(2016-04-27) Thanaporn Wattanakul; Pramote Teerapong; Katherine Plewes; Paul N. Newton; Wirongrong Chierakul; Kamolrat Silamut; Kesinee Chotivanich; Ronnatrai Ruengweerayut; Nicholas J. White; Arjen M. Dondorp; Joel Tarning; Mahidol University; Nuffield Department of Clinical Medicine; Mahosot Hospital; Mae Sot General Hospital© 2016 Wattanakul et al. Background: Fever is an inherent symptom of malaria in both adults and children. Paracetamol (acetaminophen) is the recommended antipyretic as it is inexpensive, widely available and has a good safety profile, but patients... may not be able to take the oral drug reliably. A comparison between the pharmacokinetics of oral syrup and intramuscular paracetamol given to patients with acute falciparum malaria and high body temperature was performed. Methods: A randomized, openPublication Metadata only A robust design for identification of the Parasite Clearance Estimator(2013-11-18) Kris M. Jamsen; Stephen B. Duffull; Joel Tarning; Ric N. Price; Julie A. Simpson; University of Melbourne; University of Otago; Mahidol University; Nuffield Department of Clinical Medicine; Menzies School of Health Research; WorldWide Antimalarial Resistance Network (WWARN)profiles derived from the literature combined with key sampling constraints of no more than six samples per patient within 48 hours of initial treatment. The design was evaluated with a simulation-estimation procedure that implemented the PCE. Results... of parasite density in the blood of patients following treatment. Parasite density is measured from a capillary or venous blood sample, but this can be logistically and ethically challenging if multiple samples are required within a short time period. The aimPublication Metadata only External validation of the bilirubin-atazanavir nomogram for assessment of atazanavir plasma exposure in HIV-1-infected patients(2013-04-01) Dinko Rekić; Daniel Röshammar; Martin Bergstrand; Joel Tarning; Andrea Calcagno; Antonio D'Avolio; Vidar Ormaasen; Marie Vigan; Aurélie Barrail-Tran; Michael Ashton; Magnus Gisslén; Angela Äbelö; Goteborg University, Sahlgrenska Academy; AstraZeneca Sweden; Uppsala Universitet; Mahidol University; Nuffield Department of Clinical Medicine; Universita degli Studi di Torino; Oslo University Hospital; Universite Paris 7- Denis Diderot; Inserm; Hopital de Bicetre; Universite Paris-Sud XI; Sahlgrenska Universitetssjukhuset;non-adherence was also investigated by simulation. The bilirubin nomogram predicted suboptimal exposure in the patient populations on a ritonavir-boosted regimen with a negative predictive value of 97% (95% CI 95-100). The bilirubin nomogram... for detection of suboptimal atazanavir exposure is validated against external patient populations. The bilirubin nomogram was validated against 311 matching bilirubin and atazanavir samples from 166 HIV-1-infected Norwegian, French, and Italian patients on aPublication Metadata only Population pharmacokinetics of artemether, dihydroartemisinin, and lumefantrine in rwandese pregnant women treated for uncomplicated plasmodium falciparum Malaria(2018-10-01) Jesmin Lohy Das; Stephen Rulisa; Peter J. De Vries; Petra F. Mens; Nadine Kaligirwa; Steven Agaba; Joel Tarning; Mats O. Karlsson; Thomas P.C. Dorlo; Tergooiziekenhuizen; Antoni van Leeuwenhoek Ziekenhuis; Mahidol University; Nuffield Department of Clinical Medicine; Uppsala Universitet; Amsterdam UMC - University of Amsterdam; Malaria and TB (TRAC PLUS); University Teaching Hospital of Kigali© 2018 Lohy Das et al. The artemisinin-based combination therapy artemether-lumefantrine is commonly used in pregnant malaria patients. However, the effect of pregnancyrelated changes on exposure is unclear, and pregnancy has been associated...) trimester with uncomplicated Plasmodium falciparum malaria. These patients were enrolled from Rwamagana district hospital and received the standard fixed oral dose combination of 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. VenousPublication Metadata only Population pharmacokinetic properties of antituberculosis drugs in Vietnamese children with tuberculous meningitis(2021-01-01) Navarat Panjasawatwong; Thanaporn Wattanakul; Richard M. Hoglund; Nguyen Duc Bang; Thomas Pouplin; Wichit Nosoongnoen; Vi Nguyen Ngo; Jeremy N. Day; Joel Tarning; Faculty of Tropical Medicine, Mahidol University; Oxford University Clinical Research Unit; Mahidol University; Nuffield Department of Medicine; Pham Ngoc Thach Hospital, pyrazinamide, and ethambutol in Vietnamese children with TBM, to propose optimal dosing in these patients, and to determine the relationship between drug exposure and treatment outcome. A total of 100 Vietnamese children with TBM were treated with an 8-month... antituberculosis regimen. Nonlinear mixed-effects modeling was used to evaluate the pharmacokinetic properties of the four drugs and to simulate different dosing strategies. The pharmacokinetic properties of rifampin and pyrazinamide in plasma were describedPublication Metadata only Optimal designs for population pharmacokinetic studies of the partner drugs co-administered with artemisinin derivatives in patients with uncomplicated falciparum malaria(2012-05-03) Kris M. Jamsen; Stephen B. Duffull; Joel Tarning; Niklas Lindegardh; Nicholas J. White; Julie A. Simpson; University of Melbourne; University of Otago; Mahidol University; Centre for Tropical Medicineand were based on structural PK models from the literature and the key specifications of 100 patients with five samples per patient, with one sample taken on the seventh day of treatment. The derived optimal designs were then evaluated via a simulation...-estimation procedure. Results: For all partner drugs, designs consisting of two sampling schedules (50 patients per schedule) with five samples per patient resulted in acceptable precision of the model parameter estimates. Conclusions: The sampling schedulesPublication Metadata only Optimal designs for population pharmacokinetic studies of oral artesunate in patients with uncomplicated falciparum malaria(2011-07-05) Kris M. Jamsen; Stephen B. Duffull; Joel Tarning; Niklas Lindegardh; Nicholas White; Julie A. Simpson; University of Melbourne; University of Otago; Mahidol University; Churchill Hospitalquestionnaire sent to active malaria researchers (3-4 samples per patient, at least 15 minutes between samples). The derived optimal designs were then evaluated via simulation-estimation. Results: The derived optimal sampling windows were 17 to 29 minutes, 30...Background: Currently, population pharmacokinetic (PK) studies of anti-malarial drugs are designed primarily by the logistical and ethical constraints of taking blood samples from patients, and the statistical models that are fitted to the dataPublication Metadata only Pooled population pharmacokinetic analysis of tribendimidine for the treatment of opisthorchis viverrini infections(2019-04-01) Isabel Meister; Piyanan Assawasuwannakit; Fiona Vanobberghen; Melissa A. Penny; Peter Odermatt; Somphou Sayasone; Jörg Huwyler; Joel Tarning; Jennifer Keiser; Universitat Basel; Swiss Tropical and Public Health Institute (Swiss TPH); Mahidol University; Nuffield Department of Clinical Medicine; Ministry of Healthof cure. Modeling and simulation of exposures in patients with different weight and age combinations showed that an oral single dose of 400 mg tribendimidine attained therapeutic success in over 90% of adult patients. Our data confirmed that tribendimidine... Republic, pharmacokinetic samples were obtained from 125 adult and adolescent O. viverrini-infected patients treated with 400 mg tribendimidine following the design of a sparse sampling scheme at 20 min and 2, 7.75, 8, and 30 h after treatment using driedPublication Open Access Population pharmacokinetic properties of artemisinin in healthy male Vietnamese volunteers(2016) Sofia Birgersson; Pham Van Toi; Nguyen Thanh Truong; Nguyen Thi Dung; Michael Ashton; Tran Tinh Hien; Angela Abelö; Joel Tarning; Mahidol University. Faculty of Tropical Medicine. Mahidol‑Oxford Tropical Medicine Research UnitBackground: Artemisinin-based combination therapy is recommended as first-line anti-malarial treatment worldwide. A combination of artemisinin with the long acting drug piperaquine has shown high efficacy and tolerability in patients