Search Results - "Ackaert, Oliver"
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Bioequivalence clinical trial simulation: a case study of apalutamide administered in applesauce versus whole tablets
Published in AAPS open (01-12-2023)“…Patients who have difficulty swallowing apalutamide tablets may benefit from administration in a food vehicle that is easier to swallow. In a previous…”
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Modelling the impact of JNJ-1802, a first-in-class dengue inhibitor blocking the NS3-NS4B interaction, on in-vitro DENV-2 dynamics
Published in PLoS computational biology (01-12-2023)“…Dengue virus (DENV) is a public health challenge across the tropics and subtropics. Currently, there is no licensed prophylactic or antiviral treatment for…”
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Efficacy and safety exposure–response relationships of apalutamide in patients with metastatic castration-sensitive prostate cancer: results from the phase 3 TITAN study
Published in Cancer chemotherapy and pharmacology (01-05-2022)“…Purpose Apalutamide plus androgen-deprivation therapy (ADT) has been approved for treatment of patients with metastatic castration-sensitive prostate cancer…”
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Population Pharmacokinetics of Apalutamide and its Active Metabolite N-Desmethyl-Apalutamide in Healthy and Castration-Resistant Prostate Cancer Subjects
Published in Clinical pharmacokinetics (01-02-2020)“…Background Apalutamide is a next-generation androgen receptor inhibitor approved for treatment of subjects with high-risk, non-metastatic, castration-resistant…”
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Model‐based meta‐analysis to quantify the effects of short interfering RNA therapeutics on hepatitis B surface antigen turnover in hepatitis B‐infected mice
Published in CPT: pharmacometrics and systems pharmacology (01-05-2024)“…The objective of this study was to compare the efficacy of short interfering RNA therapeutics (siRNAs) in reducing hepatitis B surface antigen (HBsAg) levels…”
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JNJ‐4178 (AL‐335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus‐Infected Patients Without Cirrhosis: OMEGA‐1
Published in Hepatology (Baltimore, Md.) (01-06-2019)“…The combination of three direct‐acting antiviral agents (AL‐335, odalasvir, and simeprevir: JNJ‐4178 regimen) for 6 or 8 weeks demonstrated good efficacy and…”
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Pharmacokinetics of Treosulfan in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
Published in Therapeutic drug monitoring (01-08-2014)“…High-dose treosulfan is used in conditioning regimens before hematopoietic stem cell transplantation in children. Pharmacokinetic data to optimize treosulfan…”
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Mechanistic studies of the transdermal iontophoretic delivery of 5-OH-DPAT in vitro
Published in Journal of pharmaceutical sciences (01-01-2010)“…A characterization and optimization of the in vitro transdermal iontophoretic transport of 5-hydroxy-2-(N,N,-di-n-propylamino)tetralin (5-OH-DPAT) is…”
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The pharmacokinetics and pharmacological effect of (S)-5-OH-DPAT following controlled delivery with transdermal iontophoresis
Published in Journal of pharmaceutical sciences (01-07-2011)“…The pharmacokinetic (PK) and pharmacodynamic (PD) properties of the active (S)-enantiomer of the potent dopamine (DA) agonist…”
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Transdermal iontophoretic delivery of a novel series of dopamine agonists in vitro: physicochemical considerations
Published in Journal of pharmacy and pharmacology (01-06-2010)“…Objectives The transdermal iontophoretic delivery of a novel series of 2‐ aminotetralins and chromanamine‐based dopamine agonists was investigated in vitro…”
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The AAPS Journal Theme Issue: “Perspectives on Clinical Drug Development of Long-Acting Injectables”
Published in The AAPS journal (14-11-2023)Get full text
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Safety, Tolerability, and Pharmacokinetics of JNJ-1802, a Pan-serotype Dengue Direct Antiviral Small Molecule, in a Phase 1, Double-Blind, Randomized, Dose-Escalation Study in Healthy Volunteers
Published in Clinical infectious diseases (18-09-2023)“…Abstract Background Dengue is a growing global health threat with no specific antiviral drugs available for treatment or prophylaxis. This first-in-human,…”
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Modelling the impact of JNJ-1802, a first-in-class dengue inhibitor blocking the NS3-NS4B interaction, on in-vitro DENV-2 dynamics
Published in PLoS computational biology (01-12-2023)Get full text
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Model-Informed Clinical Development of 6-Monthly Injection of Paliperidone Palmitate in Patients with Schizophrenia: Dosing Strategies Guided by Population Pharmacokinetic Modeling and Simulation (Part II)
Published in European journal of drug metabolism and pharmacokinetics (01-07-2024)“…Background and Objective Paliperidone palmitate 6-month (PP6M) intramuscular (IM) injection is the longest-acting treatment available for patients with…”
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Efficacy and Safety Exposure-Response Relationships of Apalutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer
Published in Clinical cancer research (01-09-2020)“…To evaluate the relationship between exposure of apalutamide and its active metabolite, N-desmethyl-apalutamide, and selected clinical efficacy and safety…”
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Model-Informed Clinical Development of Once-Every-6-Month Injection of Paliperidone Palmitate in Patients with Schizophrenia: A Pharmacometric Bridging Approach (Part I)
Published in European journal of drug metabolism and pharmacokinetics (01-07-2024)“…Background and Objective A model-informed drug development (MIDD) approach was implemented for paliperidone palmitate (PP) 6-month (PP6M) clinical development,…”
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Blocking NS3–NS4B interaction inhibits dengue virus in non-human primates
Published in Nature (London) (23-03-2023)“…Dengue is a major health threat and the number of symptomatic infections caused by the four dengue serotypes is estimated to be 96 million 1 with annually…”
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Population Pharmacokinetic Analysis of Darunavir and Tenofovir Alafenamide in HIV-1-Infected Patients on the Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Single-Tablet Regimen (AMBER and EMERALD Studies)
Published in The AAPS journal (07-06-2021)“…The single-tablet regimen darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg has undergone phase III studies AMBER…”
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Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir
Published in The AAPS journal (01-01-2019)“…The aim of the current study was to characterize the time course of plasma concentrations of AL-335 and its main metabolites (ALS-022399 and ALS-022227) after…”
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