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Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28543950/approach-to-fingolimod-induced-lymphopenia-in-multiple-sclerosis-patients-do-we-have-a-roadmap
#1
Jagannadha Avasarala, Sandip Jain, Enrique Urrea-Mendoza
No abstract text is available yet for this article.
May 25, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28543601/influence-of-meals-and-glycemic-changes-on-qt-interval-dynamics
#2
Brenda Cirincione, Philip T Sager, Donald E Mager
Thorough QT/QTc studies have become an integral part of early drug development programs, with major clinical and regulatory implications. This analysis expands on existing pharmacodynamic models of QT interval analysis by incorporating the influence of glycemic changes on the QT interval in a semimechanistic manner. A total of 21 healthy subjects enrolled in an open-label phase 1 pilot study and provided continuous electrocardiogram monitoring and plasma glucose and insulin concentrations associated with a 24-hour baseline assessment...
May 22, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28543393/model-based-evaluation-of-exenatide-effects-on-the-qt-interval-in-healthy-subjects-following-continuous-iv-infusion
#3
Brenda Cirincione, Frank LaCreta, Philip Sager, Donald E Mager
Investigation of the cardiovascular proarrhythmic potential of a new chemical entity is now an integral part of drug development. Studies suggest that meals and glycemic changes can influence QT intervals, and a semimechanistic model has been developed that incorporates the effects of changes in glucose concentrations on heart rate (HR) and QT intervals. This analysis aimed to adapt the glucose-HR-QT model to incorporate the effects of exenatide, a drug that reduces postprandial increases in glucose concentrations...
May 22, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28543352/effect-of-albiglutide-on-cholecystokinin-induced-gallbladder-emptying-in-healthy-individuals-a-randomized-crossover-study
#4
Bonnie C Shaddinger, Malcolm A Young, Julia Billiard, David A Collins, Azra Hussaini, Antonio Nino
The glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) exenatide and lixisenatide reduce cholecystokinin (CCK)-induced gallbladder emptying in healthy subjects. It is unknown if all GLP-1 RAs share this effect; therefore, the effect of the GLP-1 RA albiglutide on gallbladder function was assessed. In this randomized, double-blind, 2-way crossover study, a single dose of subcutaneous albiglutide 50 mg or placebo was administered to 17 healthy subjects, and CCK-induced gallbladder contractility was measured by ultrasonography...
May 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28543084/population-pharmacokinetics-and-exposure-response-assessment-of-cc-292-a-potent-btk-inhibitor-in-patients-with-chronic-lymphocytic-leukemia
#5
Yan Li, Francisco Ramírez-Valle, Yongjun Xue, Judith I Ventura, Olivier Gouedard, Jay Mei, Kenichi Takeshita, Maria Palmisano, Simon Zhou
CC-292, a potent Bruton tyrosine kinase inhibitor, is under development for the treatment of B-cell malignancies. An analysis was performed to develop a population pharmacokinetic model of CC-292 and assess the influence of demographics and disease-related covariates on CC-292 exposure and to assess the exposure-response (overall response rate) relationship in patients with chronic lymphocytic leukemia. Population pharmacokinetic analysis was based on a 2-compartment base model conducted in NONMEM. Categorical exposure-response analysis was performed using logistic regression in SAS...
May 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513969/effect-of-steady-state-faldaprevir-on-pharmacokinetics-of-atorvastatin-or-rosuvastatin-in-healthy-volunteers-a-prospective-open-label-fixed-sequence-crossover-study
#6
Fenglei Huang, Kristell Marzin, Rüdiger Koenen, Klaus Peter Kammerer, Natalja Strelkowa, Mabrouk Elgadi, Anne-Marie Quinson, Sebastian Haertter
Faldaprevir (FDV) is a potent, orally administered inhibitor of hepatitis C virus protease. It inhibits multiple cytochrome P-450 enzymes and multiple membrane transporters. The objective of this study was to evaluate the effect of steady-state faldaprevir on the pharmacokinetics (PK) of a single dose of atorvastatin or rosuvastatin. In this single-center, open-label, fixed-sequence crossover study, 33 healthy adult male and female volunteers were given either atorvastatin 10 mg (n = 16) or rosuvastatin 10 mg (n = 17) on day 1...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513861/regulatory-and-ethical-issues-in-pediatric-clinical-research-recommendations-from-a-panel-discussion
#7
Nilima Kshirsagar, Soumya Swaminathan, Pramod Jog, Samir Dalwai, Roli Mathur, Chandra Shekhar, Bernd Meibohm, Y K Gupta, Nusrat Shafiq, Gangadhar Sunkara, V G Somani, Prasad Kulkarni, Brian Tseng, Dhvani Mehta
No abstract text is available yet for this article.
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513856/the-utility-of-a-population-approach-in-drug-drug-interaction-assessments-a-simulation-evaluation
#8
Diane D Wang, Yanke Yu, Nastya Kassir, Min Zhu, William D Hanley, Justin C Earp, Andrew T Chow, Manish Gupta, Chuanpu Hu
This study aims at evaluating the utility of the population pharmacokinetics approach in therapeutic protein drug-drug-interaction (DDI) assessment. Simulations were conducted for 2 representative victim drugs, methotrexate and trastuzumab, using a parallel-group design with and without the interaction drug. The effect of a perpetrator on the exposure of the victim drug is described as the ratio of clearance/apparent clearance of the victim drug given with or without the perpetrator. The power of DDI assessment was calculated as the percentage of runs with 90% confidence interval of the estimated DDI effect within 80% to 125% for the scenarios of no DDI, benchmarked with the noncompartmental approach with intensive sampling...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513852/effect-of-pentoxifylline-in-ameliorating-myocardial-injury-in-patients-with-myocardial-infarction-undergoing-thrombolytic-therapy-a-pilot-randomized-clinical-trial
#9
Hossein Namdar, Rasoul Zohori, Naser Aslanabadi, Taher Entezari-Maleki
Cell death following acute myocardial infarction (MI) is the hallmark pathology of cardiovascular disease, leading to considerable mortality and morbidity. Platelet and neutrophil activation and inflammatory cytokines, prominently TNF-α, play an important role in the development of cell death. Because pentoxifylline inhibits platelet and neutrophil activation and reduces TNF-α, this study was performed to assess the potential benefit of pentoxifylline in the reduction of myocardial injury following acute MI...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28513851/population-pharmacokinetics-of-brentuximab-vedotin-in-patients-with-cd30-expressing-hematologic-malignancies
#10
Hong Li, Tae H Han, Naomi N Hunder, Graham Jang, Baiteng Zhao
Brentuximab vedotin, a CD30-directed antibody-drug conjugate (ADC), is approved for treating certain patients with CD30-expressing hematologic malignancies. Its primary mechanism of action is the targeted delivery of a microtubule-disrupting agent, monomethyl auristatin E (MMAE), to CD30-expressing cells. A population pharmacokinetic (PopPK) analysis was conducted to characterize the PK of ADC and unconjugated MMAE in patients with CD30-expressing hematologic malignancies by compartmental analysis and to evaluate the effects of covariates on PK of the ADC...
May 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510346/lack-of-effect-of-rivipansel-on-qtc-interval-in-healthy-adult-african-american-male-subjects
#11
Brinda K Tammara, Anna Plotka, Frank E Shafer, David R J Readett, Steve Riley, Joan M Korth-Bradley
Rivipansel is a pan-selectin inhibitor in phase 3 development for the treatment of vaso-occlusive crises in patients with sickle cell disease. This single-dose, randomized, 3-period, 3-treatment (400 mg moxifloxacin open-label, 4 g rivipansel-blinded, and placebo-blinded) crossover study evaluated the effect of rivipansel on the QT/QTc interval in 48 healthy male African American subjects (age, 21-53 years; weight, 60-115 kg). Time-matched, placebo-adjusted change from baseline QT interval using Fridericia's correction method (QTcF) was determined using a repeated-measures mixed-effects model...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510339/pharmacokinetics-of-tedizolid-in-obese-and-nonobese-subjects
#12
Shawn Flanagan, Sonia L Minassian, Julie A Passarell, Jill Fiedler-Kelly, Philippe Prokocimer
No abstract text is available yet for this article.
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510323/a-systematic-review-and-pooled-analysis-of-select-safety-parameters-among-normal-healthy-volunteers-taking-placebo-in-phase-1-clinical-trials
#13
Tina C Young, Subasree Srinivasan, Marion L Vetter, Venkat Sethuraman, Zubin Bhagwagar, Ricardo Zwirtes, Premkumar Narasimhan, Tilda Chuang, Brendan J Smyth
A systematic review of the Bristol-Myers Squibb normal healthy volunteers (NHVs) database identified phase 1 trials that included NHVs administered placebo with the aim of characterizing normal inter- and intraindividual safety parameter variability. Twenty-five single and multiple ascending dose studies, median duration 28 (2 to 63) days, were included in the pooled analysis (355 NHVs). Laboratory evaluations, vital signs, electrocardiograms, and adverse events were assessed. The most commonly occurring adverse event was headache (28 [7...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510322/does-medical-students-knowing-more-about-drugs-lead-to-better-treatment-choices
#14
LETTER
David J Brinkman, Anna P van Rossem, Jelle Tichelaar, Milan C Richir, Michiel A van Agtmael
No abstract text is available yet for this article.
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510304/flip-flop-phenomenon-in-epidural-sufentanil-pharmacokinetics-a-population-study-in-children-and-infants
#15
Agnieszka Borsuk, Bogumiła Wołoszczuk-Gębicka, Alicja Bartkowska-Śniatkowska, Jowita Rosada-Kurasińska, Agnieszka Bienert, Paweł Wiczling
The aims of this study were to develop a population pharmacokinetic model of sufentanil coadministered with 0.2% ropivacaine as an epidural infusion in infants and describe the sufentanil absorption profile from epidural space. Data from 2 previously published studies were merged for analysis-20 infants aged 3-36 months receiving sufentanil as an epidural infusion and 41 children 0-17 years old receiving sufentanil as a long-term intravenous infusion. A population nonlinear mixed-effects model was built in NONMEM...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28510296/pharmacokinetics-and-safety-of-single-dose-inhaled-loxapine-in-children-and-adolescents
#16
Sally Selim, Robert Riesenberg, James Cassella, Jeevan Kunta, Edward Hellriegel, Mark A Smith, Alexander A Vinks, Laura Rabinovich-Guilatt
This multisite open-label study sought to characterize the pharmacokinetics and safety of a single dose of inhaled loxapine in children and adolescents. Loxapine powder for oral inhalation was administered via a single-use handheld drug device to children and adolescents (aged 10-17 years) with any condition warranting chronic antipsychotic use. Patients were dosed according to body weight and cohort (<50 kg [n = 15], 2.5 or 5 mg; ≥50 kg [n = 15], 5 or 10 mg); the first 6 patients (cohort 1) enrolled in each weight group received the lower dose...
May 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28467638/electrophysiological-adverse-effects-of-direct-acting-antivirals-in-patients-with-chronic-hepatitis-c
#17
LETTER
Roberto Rossotti, Lucio Jesus Garcia-Fraile Fraile, Chiara Baiguera, Massimo Puoti
No abstract text is available yet for this article.
May 3, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28467634/generic-and-branded-docetaxel
#18
LETTER
Nour Al Faqeer, Lama Nazer
No abstract text is available yet for this article.
May 3, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28467604/generic-docetaxel
#19
LETTER
Dominique Levêque, Guillaume Becker
No abstract text is available yet for this article.
May 3, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28467601/reply-to-letter-influence-of-liver-and-kidney-disease-on-sofosbuvir-electrophysiological-effects
#20
LETTER
Martina Vitrone, Antonio Parrella, Emanuele Durante-Mangoni
No abstract text is available yet for this article.
May 3, 2017: Journal of Clinical Pharmacology
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