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Clinical Pharmacokinetics

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https://www.readbyqxmd.com/read/28425029/comparison-of-a-novel-formulation-of-abiraterone-acetate-vs-the-originator-formulation-in-healthy-male-subjects-two-randomized-open-label-crossover-studies
#1
Ronald Goldwater, Azra Hussaini, Bill Bosch, Paul Nemeth
BACKGROUND AND OBJECTIVE: Abiraterone acetate is approved for the treatment of metastatic castration-resistant prostate cancer. The originator abiraterone acetate (OAA) formulation is poorly absorbed and exhibits large pharmacokinetic variability in abiraterone exposure. Abiraterone acetate fine particle (AAFP) is a proprietary formulation (using SoluMatrix Fine Particle Technology™) designed to increase the oral bioavailability of abiraterone acetate. Here, we report on two phase I studies in healthy male subjects aged 18-50 years...
April 19, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28417439/clinical-pharmacokinetics-of-sacubitril-valsartan-lcz696-a-novel-angiotensin-receptor-neprilysin-inhibitor
#2
REVIEW
Surya Ayalasomayajula, Thomas Langenickel, Parasar Pal, Sreedevi Boggarapu, Gangadhar Sunkara
Sacubitril/valsartan (LCZ696) is indicated for the treatment of heart failure with reduced ejection fraction. Absorption of sacubitril/valsartan and conversion of sacubitril (prodrug) to sacubitrilat (neprilysin inhibitor) was rapid with maximum plasma concentrations of sacubitril, sacubitrilat, and valsartan (angiotensin receptor blocker) reaching within 0.5, 1.5-2.0, and 2.0-3.0 h, respectively. With a two-fold increase in dose, an increase in the area under the plasma concentration-time curve was proportional for sacubitril, ~1...
April 17, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28409488/a-joint-model-for-vitamin-k-dependent-clotting-factors-and-anticoagulation-proteins
#3
Qing Xi Ooi, Daniel F B Wright, R Campbell Tait, Geoffrey K Isbister, Stephen B Duffull
BACKGROUND: Warfarin acts by inhibiting the reduction of vitamin K (VK) to its active form, thereby decreasing the production of VK-dependent coagulation proteins. The aim of this research is to develop a joint model for the VK-dependent clotting factors II, VII, IX and X, and the anticoagulation proteins, proteins C and S, during warfarin initiation. METHODS: Data from 18 patients with atrial fibrillation who had warfarin therapy initiated were available for analysis...
April 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28405936/population-pharmacokinetics-some-observations-in-pediatric-modeling-for-drug-clearance
#4
Iftekhar Mahmood, Million A Tegenge
The objective of this study is to evaluate the predictive performance of several models to predict drug clearance in preterm and term neonates. Five models using different types of allometric and linear models were developed. Two sets of data were used to develop these models (data from preterm neonates to adults and data from preterm and term neonates). Models were also developed with (normalized to 70 kg) or without body weight normalization (body weight 1 kg). From the literature, clearance values for four drugs from neonates to adults were obtained...
April 12, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28401480/target-mediated-drug-disposition-pharmacokinetic-pharmacodynamic-model-of-bosentan-and-endothelin-1
#5
Anke-Katrin Volz, Andreas Krause, Walter Emil Haefeli, Jasper Dingemanse, Thorsten Lehr
BACKGROUND AND OBJECTIVES: Bosentan is a competitive antagonist on endothelin receptor A and B (ETA and ETB), displacing the endogenous binding partner endothelin-1 (ET-1) from its binding sites. After administration of escalating single doses of 10-750 mg as an intravenous (i.v.) infusion, bosentan showed dose-dependent pharmacokinetics (PK). The aim of this analysis was to develop a PK model of bosentan after i.v. administration including competitive antagonism with ET-1 and to analyze its influence on blood pressure and heart rate with a combined pharmacokinetic/pharmacodynamic (PK/PD) model...
April 11, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28401479/gestation-specific-changes-in-the-anatomy-and-physiology-of-healthy-pregnant-women-an-extended-repository-of-model-parameters-for-physiologically-based-pharmacokinetic-modeling-in-pregnancy
#6
REVIEW
André Dallmann, Ibrahim Ince, Michaela Meyer, Stefan Willmann, Thomas Eissing, Georg Hempel
BACKGROUND: In the past years, several repositories for anatomical and physiological parameters required for physiologically based pharmacokinetic modeling in pregnant women have been published. While providing a good basis, some important aspects can be further detailed. For example, they did not account for the variability associated with parameters or were lacking key parameters necessary for developing more detailed mechanistic pregnancy physiologically based pharmacokinetic models, such as the composition of pregnancy-specific tissues...
April 11, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28397081/a-bayesian-approach-for-population-pharmacokinetic-modeling-of-pegylated-interferon-%C3%AE-2a-in-hepatitis-c-patients
#7
Mohammad I Saleh
BACKGROUND: Pegylated interferon α-2a (PEG-IFN-α-2a) is an antiviral drug used for the treatment of chronic hepatitis C virus (HCV) infection. This study describes the population pharmacokinetics of PEG-IFN-α-2a in hepatitis C patients using a Bayesian approach. A possible association between patient characteristics and pharmacokinetic parameters is also explored. METHODS: A Bayesian population pharmacokinetic modeling approach, using WinBUGS version 1.4.3, was applied to a cohort of patients (n = 292) with chronic HCV infection...
April 10, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28391404/physiologically-based-pharmacokinetic-modeling-of-renally-cleared-drugs-in-pregnant-women
#8
André Dallmann, Ibrahim Ince, Juri Solodenko, Michaela Meyer, Stefan Willmann, Thomas Eissing, Georg Hempel
BACKGROUND: Since pregnant women are considerably underrepresented in clinical trials, information on optimal dosing in pregnancy is widely lacking. Physiologically based pharmacokinetic (PBPK) modeling may provide a method for predicting pharmacokinetic changes in pregnancy to guide subsequent in vivo pharmacokinetic trials in pregnant women, minimizing associated risks. OBJECTIVES: The goal of this study was to build and verify a population PBPK model that predicts the maternal pharmacokinetics of three predominantly renally cleared drugs (namely cefazolin, cefuroxime, and cefradine) at different stages of pregnancy...
April 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28389935/population-pharmacokinetics-and-bayesian-estimators-for-refined-dose-adjustment-of-a-new-tacrolimus-formulation-in-kidney-and-liver-transplant-patients
#9
Jean-Baptiste Woillard, Jean Debord, Caroline Monchaud, Franck Saint-Marcoux, Pierre Marquet
BACKGROUND AND OBJECTIVES: A new once-daily formulation of tacrolimus (Envarsus(®)) has recently been developed, with alleged different pharmacokinetics from previous tacrolimus formulations. The objectives of this study were to develop population pharmacokinetic models and Bayesian estimators based on limited sampling strategies for Envarsus(®) in kidney and liver transplant recipients. MATERIALS AND METHODS: Full tacrolimus concentration-time profiles (13 samples) were drawn from 57 liver (113 profiles) and 49 kidney (97 profiles) graft recipients transplanted for at least 6 months and switched from Prograf(®) to Envarsus(®)...
April 8, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28357715/no-dose-adjustment-is-recommended-for-digoxin-warfarin-atorvastatin-or-a-combination-oral-contraceptive-when-coadministered-with-dulaglutide
#10
Amparo de la Peña, Xuewei Cui, Jeanne Geiser, Corina Loghin
BACKGROUND: Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) for the treatment of type 2 diabetes mellitus are known to delay gastric emptying (GE). The potential effect of the GLP-1 RA dulaglutide on the pharmacokinetics (PK) of four orally administered drugs and on the pharmacodynamic (PD) effect of warfarin was investigated. METHODS: In four separate clinical pharmacology studies, digoxin, warfarin, atorvastatin and Ortho-Cyclen(®) were orally administered to healthy subjects with and without a subcutaneous dose of dulaglutide 1...
March 29, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28353057/levetiracetam-clinical-pharmacokinetic-monitoring-in-pediatric-patients-with-epilepsy
#11
REVIEW
Jason Tan, Vanessa Paquette, Marc Levine, Mary H H Ensom
Levetiracetam is a broad-spectrum antiepileptic drug (AED) with a unique mechanism of action. Older AEDs can cause serious short- and long-term adverse drug reactions and complications, rendering them undesirable to use in pediatric patients. Characteristics that make levetiracetam a near-ideal AED include its broad spectrum of activity, good tolerability profile, and minimal drug-drug interactions. Clinical pharmacokinetic monitoring (CPM) is often recommended in pediatric patients for certain AEDs due to large interindividual pharmacokinetic differences and unpredictable drug disposition...
March 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28353056/pharmacokinetics-of-escalating-doses-of-oral-psilocybin-in-healthy-adults
#12
Randall T Brown, Christopher R Nicholas, Nicholas V Cozzi, Michele C Gassman, Karen M Cooper, Daniel Muller, Chantelle D Thomas, Scott J Hetzel, Kelsey M Henriquez, Alexandra S Ribaudo, Paul R Hutson
INTRODUCTION: Psilocybin is a psychedelic tryptamine that has shown promise in recent clinical trials for the treatment of depression and substance use disorders. This open-label study of the pharmacokinetics of psilocybin was performed to describe the pharmacokinetics and safety profile of psilocybin in sequential, escalating oral doses of 0.3, 0.45, and 0.6 mg/kg in 12 healthy adults. METHODS: Eligible healthy adults received 6-8 h of preparatory counseling in anticipation of the first dose of psilocybin...
March 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28353055/accounting-for-pharmacokinetic-variability-of-certolizumab-pegol-in-patients-with-crohn-s-disease
#13
Niels Vande Casteele, Diane R Mould, Jason Coarse, Iram Hasan, Ann Gils, Brian Feagan, William J Sandborn
BACKGROUND: Certolizumab pegol is an effective biologic for patients with Crohn's disease (CD). Individual differences in certolizumab pegol apparent clearance (CL/F) affect exposure and possibly efficacy. A previously developed population pharmacokinetic (PK) model did not account for dynamic changes in clinical parameters during therapy. OBJECTIVE: The aim of this study was to refine the existing PK model to capture the time-varying influence of covariates. METHODS: Data collected from 2157 Crohn's disease patients in nine studies were analyzed using nonlinear mixed-effects modeling software (NONMEM)...
March 28, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28349387/effect-of-semaglutide-on-the-pharmacokinetics-of-metformin-warfarin-atorvastatin-and-digoxin-in-healthy-subjects
#14
Helene Hausner, Julie Derving Karsbøl, Anders G Holst, Jacob B Jacobsen, Frank-Dietrich Wagner, Georg Golor, Thomas W Anderson
BACKGROUND AND OBJECTIVE: Semaglutide is a glucagon-like peptide-1 analogue in development for the once-weekly treatment of type 2 diabetes mellitus. Its effect on the rate and extent of absorption of concomitant oral medications (metformin, warfarin, atorvastatin and digoxin) was evaluated in healthy subjects. METHODS: Subjects received metformin (500 mg twice daily for 3.5 days), warfarin (25 mg, single dose), atorvastatin (40 mg, single dose) or digoxin (0...
March 27, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28349386/pharmacokinetics-and-tolerability-of-a-single-dose-of-semaglutide-a-human-glucagon-like-peptide-1-analog-in-subjects-with-and-without-renal-impairment
#15
Thomas C Marbury, Anne Flint, Jacob B Jacobsen, Julie Derving Karsbøl, Kenneth Lasseter
BACKGROUND: The pharmacokinetics and tolerability of semaglutide, a once-weekly human glucagon-like peptide-1 analog in development for the treatment of type 2 diabetes mellitus, were investigated in subjects with/without renal impairment (RI). METHODS: Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg. Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity...
March 27, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28343293/pharmacokinetic-and-pharmacodynamic-considerations-in-the-treatment-of-chronic-lymphocytic-leukemia-ibrutinib-idelalisib-and-venetoclax
#16
REVIEW
Madeline Waldron, Allison Winter, Brian T Hill
Management of chronic lymphocytic leukemia has changed markedly over the last several years with the emergence of several novel oral agents targeting B-cell receptor and Bcl-2 signaling pathways. For patients requiring treatment, ibrutinib, idelalisib, and venetoclax offer unique clinical benefits with a different set of therapeutic considerations compared with traditional parenteral therapy. Despite the conveniences afforded by oral therapy, these agents also carry unique logistical obstacles. Drug interactions with agents that are metabolized via the cytochrome P450 3A4 pathway are possible with all three agents...
March 25, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28290122/scientific-rationale-for-determining-the-bioequivalence-of-inhaled-drugs
#17
REVIEW
Omar S Usmani, Mathieu Molimard, Vaibhav Gaur, Jaideep Gogtay, Gur Jai Pal Singh, Geena Malhotra, Eric Derom
In recent years, pathways for the development and approval of bioequivalent inhaled products have been established for regulated markets, including the European Union (EU), and a number of orally inhaled products (OIPs) have been approved in the EU solely on the basis of in vitro and pharmacokinetic data. This review describes how these development pathways are structured and their implications for the treatment of airway diseases such as asthma. The EU guidance follows a stepwise approach that includes in vitro criteria as the first step...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28290121/population-pharmacokinetic-analysis-of-ixazomib-an-oral-proteasome-inhibitor-including-data-from-the-phase-iii-tourmaline-mm1-study-to-inform-labelling
#18
Neeraj Gupta, Paul M Diderichsen, Michael J Hanley, Deborah Berg, Helgi van de Velde, R Donald Harvey, Karthik Venkatakrishnan
Ixazomib is an oral proteasome inhibitor, approved in USA, Canada, Australia and Europe in combination with lenalidomide and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. We report a population pharmacokinetic model-based analysis for ixazomib that was pivotal in describing the clinical pharmacokinetics of ixazomib, to inform product labelling. Plasma concentration-time data were collected from 755 patients who received oral or intravenous ixazomib in once- or twice-weekly schedules in ten trials, including the global phase III TOURMALINE-MM1 study...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28290120/development-of-a-pediatric-physiologically-based-pharmacokinetic-model-of-clindamycin-using-opportunistic-pharmacokinetic-data
#19
Christoph P Hornik, Huali Wu, Andrea N Edginton, Kevin Watt, Michael Cohen-Wolkowiez, Daniel Gonzalez
Physiologically-based pharmacokinetic (PBPK) modeling is a powerful tool used to characterize maturational changes in drug disposition to inform dosing across childhood; however, its use is limited in pediatric drug development. Access to pediatric pharmacokinetic data is a barrier to widespread application of this model, which impedes its development and optimization. To support the development of a pediatric PBPK model, we sought to leverage opportunistically-collected plasma concentrations of the commonly used antibiotic clindamycin...
March 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28290119/time-to-seizure-modeling-of-lacosamide-used-in-monotherapy-in-patients-with-newly-diagnosed-epilepsy
#20
Andreas Lindauer, Christian Laveille, Armel Stockis
OBJECTIVES: To quantify the relationship between exposure to lacosamide monotherapy and seizure probability, and to simulate the effect of changing the dose regimen. METHODS: Structural time-to-event models for dropouts (not because of a lack of efficacy) and seizures were developed using data from 883 adult patients newly diagnosed with epilepsy and experiencing focal or generalized tonic-clonic seizures, participating in a trial (SP0993; ClinicalTrials.gov identifier: NCT01243177) comparing the efficacy of lacosamide and carbamazepine controlled-release monotherapy...
March 13, 2017: Clinical Pharmacokinetics
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