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https://www.readbyqxmd.com/read/29159710/prediction-of-free-from-total-mycophenolic-acid-concentrations-in-stable-renal-transplant-patients-a-population-based-approach
#1
Helena Colom, Franc Andreu, Teun van Gelder, Dennis A Hesselink, Brenda C M de Winter, Oriol Bestard, Joan Torras, Josep M Cruzado, Josep M Grinyó, Núria Lloberas
BACKGROUND: A population pharmacokinetic (PK) protein-binding model was developed to (1) predict free mycophenolic acid (fMPA) based on total MPA (tMPA) concentrations in renal transplant patients, to establish the therapeutic range of fMPA through pharmacokinetic-pharmacodynamic studies; and (2) provide a guideline for dosing mycophenolate mofetil (MMF). METHODS: Full PK profiles of 56 patients (from five different occasions) during the first year after transplantation who were treated with oral MMF and cyclosporine, or macrolides (either tacrolimus or sirolimus), were analysed...
November 20, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29150770/population-in-vitro-in-vivo-pharmacokinetic-model-of-first-pass-metabolism-itraconazole-and-hydroxy-itraconazole
#2
Ahmad Y Abuhelwa, Stuart Mudge, Richard N Upton, David J R Foster
The aim of this study was to develop a population in vitro-in vivo pharmacokinetic model that simultaneously describe the absorption and accumulation kinetics of itraconazole (ICZ) and hydroxy-itraconazole (HICZ) in healthy subjects. The model integrated meta-models of gastrointestinal pH and gastrointestinal transit time and in vitro dissolution models of ICZ with the absorption and disposition kinetics of ICZ and HICZ. Mean concentration intravenous data, and single- and multi-dose oral data were used for model development...
November 17, 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/29136160/highly-variable-absorption-of-clavulanic-acid-during-the-day-a-population-pharmacokinetic-analysis
#3
Femke De Velde, Brenda C M De Winter, Birgit C P Koch, Teun Van Gelder, Johan W Mouton
Objectives: To calculate the clavulanic acid exposure of oral amoxicillin/clavulanic acid dosing regimens, to investigate variability using a population pharmacokinetic model and to explore target attainment using Monte Carlo simulations. Methods: Two groups of healthy male volunteers received amoxicillin/clavulanic acid tablets at the start of a standard meal on two separate days 1 week apart. One group (n = 14) received 875/125 mg q12h and 500/125 mg q8h and the other group (n = 15) received 500/125 mg q12h and 250/125 mg q8h...
November 9, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29106979/development-of-a-population-pharmacokinetic-model-to-predict-brain-distribution-and-dopamine-d2-receptor-occupancy-of-raclopride-in-non-anesthetized-rat
#4
Yin Cheong Wong, Trayana Ilkova, Rob C van Wijk, Robin Hartman, Elizabeth C M de Lange
BACKGROUND: Raclopride is a selective antagonist of the dopamine D2 receptor. It is one of the most frequently used in vivo D2 tracers (at low doses) for assessing drug-induced receptor occupancy (RO) in animals and humans. It is also commonly used as a pharmacological blocker (at high doses) to occupy the available D2 receptors and antagonize the action of dopamine or drugs on D2 in preclinical studies. The aims of this study were to comprehensively evaluate its pharmacokinetic (PK) profiles in different brain compartments and to establish a PK-RO model that could predict the brain distribution and RO of raclopride in the freely moving rat using a LC-MS based approach...
November 4, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29077992/population-pharmacokinetics-of-exendin-9-39-and-clinical-dose-selection-in-patients-with-congenital-hyperinsulinism
#5
Chee M Ng, Fei Tang, Steven Seeholzer, Yixuan Zou, Diva D De León
AIMS: Congenital hyperinsulinism (HI) is the most common cause of persistent hypoglycaemia in infants and children. Exendin-(9-39), an inverse glucagon-like peptide 1 (GLP-1) agonist, is a novel therapeutic agent for HI that has demonstrated glucose-raising effect. We reported the first population pharmacokinetic (PopPK) model of the exendin-(9-39) in patients with HI and proposed the optimal dosing regimen for future clinical trials in neonates with HI. METHODS: 182 pharmacokinetic (PK) observations from 26 subjects in three clinical studies were included for constructing the PopPK model using FOCE with interaction method in NONMEM...
October 27, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29045766/population-pharmacodynamic-analysis-of-uric-acid-lowering-effects-of-febuxostat-based-on-electronic-medical-records-in-two-hospitals
#6
Shota Muraki, Kuniaki Moriki, Saki Shigematsu, Masato Fukae, Makoto Kakara, Daiki Yamashita, Takeshi Hirota, Hiroshi Takane, Miki Shimada, Masaaki Hirakawa, Ichiro Ieiri
The aim of this study was to develop a population pharmacodynamic (PPD) model to describe uric acid (UA)-lowering effects in patients treated with febuxostat based on electronic medical records in 2 independent hospitals (university and city hospitals). Interhospital differences in the PPD model were also evaluated. We conducted the following 2 approaches to build the PPD models. A PPD model was developed separately using individual hospital data, and structural models and covariates between the two hospitals were compared (approach A)...
October 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29032112/dermal-pharmacokinetics-of-pyrazinamide-determined-by-microdialysis-sampling-in-rats
#7
Nivea M F Voelkner, Alexander Voelkner, Juliana Costa, Sherwin K B Sy, Juliane Hermes, Johanna Weitzel, Sebastian Morales, Hartmut Derendorf
Studies have demonstrated pyrazinamide's efficacy against stages of the parasite which causes cutaneous leishmaniasis. Although pyrazinamide is widely distributed to most fluids and tissues, the drug distribution that reaches the skin is unknown. The aim of this study was to investigate pyrazinamide pharmacokinetics in rat dermal tissue by dermal microdialysis. Skin pharmacokinetics were assessed by implanting a linear microdialysis probe in the dermis of ten rats. Additionally, blood samples were collected for assessing plasma pharmacokinetics...
October 12, 2017: International Journal of Antimicrobial Agents
https://www.readbyqxmd.com/read/29029267/evaluation-of-universal-versus-genotype-guided-efavirenz-dose-reduction-in-pregnant-women-using-population-pharmacokinetic-modelling
#8
Adeniyi Olagunju, Alessandro Schipani, Oluseye Bolaji, Saye Khoo, Andrew Owen
Objectives: Lack of data on the pharmacokinetics of efavirenz in pregnant women at the 400 mg reduced dose currently prevents universal roll-out. Population pharmacokinetic modelling was used to explore pharmacokinetic endpoints at 200, 400 and 600 mg daily doses in pregnant women stratified by CYP2B6 metabolic status. Methods: The analysis was based on 252 plasma efavirenz concentrations from 77 pregnant women (77 sparse, 175 intensive) who received antiretroviral regimens containing 600 mg of efavirenz...
September 26, 2017: Journal of Antimicrobial Chemotherapy
https://www.readbyqxmd.com/read/29018999/population-pharmacokinetics-of-gabapentin-in-healthy-korean-subjects-with-influence-of-genetic-polymorphisms-of-abcb1
#9
Phuong Tran, Hee-Doo Yoo, Lien Ngo, Hea-Young Cho, Yong-Bok Lee
The objective of this study was to perform population pharmacokinetic (PK) analysis of gabapentin in healthy Korean subjects and to investigate the possible effect of genetic polymorphisms (1236C > T, 2677G > T/A, and 3435C > T) of ABCB1 gene on PK parameters of gabapentin. Data were collected from bioequivalence studies, in which 173 subjects orally received three different doses of gabapentin (300, 400, and 800 mg). Only data from reference formulation were used. Population pharmacokinetics (PKs) of gabapentin was estimated using a nonlinear mixed-effects model (NONMEM)...
December 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28991252/population-pharmacokinetics-and-pharmacodynamics-of-mycophenolic-acid-using-the-prospective-data-in-patients-undergoing-hematopoietic-stem-cell-transplantation
#10
K Yoshimura, I Yano, T Yamamoto, M Kawanishi, Y Isomoto, A Yonezawa, T Kondo, A Takaori-Kondo, K Matsubara
Mycophenolate mofetil (MMF), a prodrug of mycophenolic acid (MPA), is used to suppress GvHD in patients undergoing hematopoietic stem cell transplantation (HCT). The purpose of this study was to construct a population pharmacokinetic and pharmacodynamic model in HCT patients for individualized MPA therapy. Blood samples were obtained from 49 HCT patients after starting MMF therapy. Population pharmacokinetic and pharmacodynamic parameters were obtained using the program NONMEM. MPA was described via a one-compartment model with a first-order elimination, and 30...
October 9, 2017: Bone Marrow Transplantation
https://www.readbyqxmd.com/read/28937536/enoxaparin-population-pharmacokinetics-in-the-first-year-of-life
#11
Brady S Moffett, Marianne Galati, Donald Mahoney, YoungNa Lee-Kim, Jun Teruya, Mona D Shah, Donald L Yee
AIMS: Enoxaparin dosing requirements in the first year of life can be highly variable. Characterization of pharmacokinetics in this patient population can assist in dosing. METHODS: Patients less than 1 year postnatal age who received enoxaparin and had an anti-factor Xa activity level drawn as inpatients were identified through the pharmacy database over a 5-year period. Patients on renal replacement therapy or with hyperbilirubinemia were excluded. Data collection included demographic variables, indication for enoxaparin, enoxaparin doses, anti-factor Xa activity levels, serum creatinine, hemoglobin, hematocrit, platelet count, and urine output over the previous 24 hours...
December 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28937535/validation-of-a-commercial-assay-and-decision-support-tool-for-routine-paclitaxel-therapeutic-drug-monitoring-tdm
#12
Markus Joerger, Stefanie Kraff, Ulrich Jaehde, Ralf A Hilger, Jodi B Courtney, Daniel J Cline, Sonali Jog, Irina Baburina, M Craig Miller, Salvatore J Salamone
BACKGROUND: The value of therapeutic drug monitoring (TDM) for paclitaxel (PTX) was recently demonstrated in the largest TDM trial ever conducted in oncology. The trial demonstrated significant reduction in neuropathy when using TDM. Dose adjustment for PTX was based on time above a threshold concentration (Tc>0.05). Tc>0.05 must be calculated with a pharmacokinetic model and complex nonlinear mixed-effects software. The use of the software and chromatographic methods to measure PTX requires specialized expertise...
December 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28928162/therapeutic-drug-monitoring-of-carboplatin-in-high-dose-protocol-ti-ce-for-advanced-germ-cell-tumors-pharmacokinetic-results-of-a-phase-2-multicenter-study
#13
Sotheara Moeung, Christine Chevreau, Sophie Broutin, Jérôme Guitton, Bénédicte Lelièvre, Joseph Ciccolini, Christophe Massard, Aude Fléchon, Rémy Delva, Gwenaëlle Gravis, Jean-Pierre Lotz, Jacques-Olivier Bay, Marine Gross-Goupil, Angelo Paci, Sabrina Marsili, Laurence Malard, Etienne Chatelut, Fabienne Thomas
PURPOSE: We aimed to evaluate the performance of therapeutic drug monitoring (TDM) approach in controlling inter-patient variability of carboplatin exposure (AUC) in patients treated with TI-CE high-dose chemotherapy for advanced germ cell tumors and to assess the possibility of using a formula-based dosing method as a possible alternative. EXPERIMENTAL DESIGN: Eighty nine patients receiving carboplatin for 3 consecutive days during 3 cycles were evaluable for pharmacokinetic study...
September 19, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28926095/model-based-assessment-using-conventional-bioequivalence-limits-to-ensure-safety-and-efficacy-of-rivaroxaban-in-patients-undergoing-hip-or-knee-replacement
#14
Mario González-Sales, Lanyan Fang, Myong-Jin Kim, Liang Zhao
We evaluated whether the current bioequivalence limit is adequate to ensure safety and efficacy of rivaroxaban in patients under total hip arthroplasty and total knee arthroplasty based on its model informed benefit/risk profile. Clinical data from a total of 7145 patients from 3 phase 2 and 4 phase 3 clinical trials were included in the current model-based exposure-response analysis. The relationships between rivaroxaban exposure measurements (ie, minimum or trough, maximum, average concentration, and area under the concentration-time curve [AUC] at steady state) and clinical outcomes (ie, the probabilities of major bleeding [MB] and venous thromboembolism [VTE]) were modeled using NONMEM 7...
September 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28925806/population-pharmacokinetics-of-arginine-glutamate-in-healthy-chinese-volunteers
#15
Jing Wang, Heng Zheng, Kun Wang, Zheng Wang, Yufeng Ding
1. The present study developed population pharmacokinetic models of arginine and glutamate in healthy Chinese volunteers. Two nonlinear mixed-effect models were developed using NONMEM® software (ICON Development Solutions, Ellicott City, MD) to describe the pharmacokinetic properties and to assess the relevant parameters as well as the inter-individual variability. The potential covariates were screened using stepwise approach and the stability and predictive capability of the models were performed using bootstrap and visual predictive check...
September 19, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28918602/population-pharmacokinetics-and-optimal-sampling-strategy-for-model-based-precision-dosing-of-melphalan-in-patients-undergoing-hematopoietic-stem-cell-transplantation
#16
Kana Mizuno, Min Dong, Tsuyoshi Fukuda, Sharat Chandra, Parinda A Mehta, Scott McConnell, Elias J Anaissie, Alexander A Vinks
BACKGROUND: High-dose melphalan is an important component of conditioning regimens for patients undergoing hematopoietic stem cell transplantation. The current dosing strategy based on body surface area results in a high incidence of oral mucositis and gastrointestinal and liver toxicity. Pharmacokinetically guided dosing will individualize exposure and help minimize overexposure-related toxicity. OBJECTIVE: The purpose of this study was to develop a population pharmacokinetic model and optimal sampling strategy...
September 16, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28918591/platform-model-describing-pharmacokinetic-properties-of-vc-mmae-antibody-drug-conjugates
#17
Matts Kågedal, Leonid Gibiansky, Jian Xu, Xin Wang, Divya Samineni, Shang-Chiung Chen, Dan Lu, Priya Agarwal, Bei Wang, Ola Saad, Neelima Koppada, Bernard M Fine, Jin Y Jin, Sandhya Girish, Chunze Li
Antibody-drug conjugates (ADCs) developed using the valine-citrulline-MMAE (vc-MMAE) platform, consist of a monoclonal antibody (mAb) covalently bound with a potent anti-mitotic toxin (MMAE) through a protease-labile vc linker. Recently, clinical data for a variety of vc-MMAE ADCs has become available. The goal of this analysis was to develop a platform model that simultaneously described antibody-conjugated MMAE (acMMAE) pharmacokinetic (PK) data from eight vc-MMAE ADCs, against different targets and tumor indications; and to assess differences and similarities of model parameters and model predictions, between different compounds...
December 2017: Journal of Pharmacokinetics and Pharmacodynamics
https://www.readbyqxmd.com/read/28914344/influence-of-genetic-co-factors-on-the-population-pharmacokinetic-model-for-clopidogrel-and-its-active-thiol-metabolite
#18
Dorota Danielak, Marta Karaźniewicz-Łada, Anna Komosa, Paweł Burchardt, Maciej Lesiak, Łukasz Kruszyna, Agnieszka Graczyk-Szuster, Franciszek Główka
PURPOSE: A high interindividual variability is observed in the pharmacokinetics of clopidogrel, a widely used antiplatelet drug. In the present study, a joint parent-metabolite population pharmacokinetic model was developed to adequately describe observed concentrations of clopidogrel and its active thiol metabolite (H4). METHODS: The study included 63 patients undergoing elective coronarography or percutaneous coronary intervention. The population pharmacokinetic model was developed in the NONMEM 7...
September 15, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28887801/population-pharmacokinetic-and-pharmacodynamic-analysis-of-belimumab-administered-subcutaneously-in-healthy-volunteers-and-patients-with-systemic-lupus-erythematosus
#19
Herbert Struemper, Mita Thapar, David Roth
BACKGROUND: Intravenous belimumab 10 mg/kg every 4 weeks is indicated in patients with active, autoantibody-positive systemic lupus erythematosus receiving standard systemic lupus erythematosus care. Subcutaneous 200-mg weekly administration, which may prove more convenient for patients and improve adherence, is currently under investigation. OBJECTIVE: The objective of this study was to characterize the population pharmacokinetics and exposure-efficacy response of subcutaneous belimumab in a pooled analysis of pharmacokinetic data [phase I: BEL114448 (NCT01583530) and BEL116119 (NCT01516450) in healthy subjects (n = 134); phase III: BEL112341 (NCT01484496) in adults with systemic lupus erythematosus (n = 554)] and pharmacodynamic data [BEL112341 in adults with systemic lupus erythematosus (n = 833)]...
September 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28854543/dexmedetomidine-pharmacodynamics-in-healthy-volunteers-2-haemodynamic-profile
#20
P J Colin, L N Hannivoort, D J Eleveld, K M E M Reyntjens, A R Absalom, H E M Vereecke, M M R F Struys
Background: Dexmedetomidine, a selective α 2 -adrenoreceptor agonist, has unique characteristics, with little respiratory depression and rousability during sedations. We characterized the haemodynamic properties of dexmedetomidine by developing a pharmacokinetic-pharmacodynamic (PKPD) model with a focus on changes in mean arterial blood pressure (MAP) and heart rate. Methods: Dexmedetomidine was delivered i.v. to 18 healthy volunteers in a step-up fashion by target-controlled infusion using the Dyck model...
August 1, 2017: British Journal of Anaesthesia
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