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Journal of Clinical Pharmacology

Dong W Chang, Jonathan Grotts, Chi-Hong Tseng, Eric P Brass
No abstract text is available yet for this article.
October 6, 2016: Journal of Clinical Pharmacology
Iftekhar Mahmod, Tasneem Ahmad, Najia Mansoor, S M Sharib
The objective of this study was to evaluate the predictive performances of allometric models and a physiologically based pharmacokinetic model (PBPK) to predict clearance of glucuronidated drugs in neonates (≤3 months of age). From the literature, clearance values for 9 drugs (glucuronidated) for neonates and adults were obtained. Three allometric models were used to predict clearances of these glucuronidated drugs. A PBPK model was developed using the physicochemical, biopharmaceutical, and metabolic properties together with known pediatric physiology and enzymatic ontogeny...
October 4, 2016: Journal of Clinical Pharmacology
Masahiro Shimamura, Jun Miyakawa, Masaaki Doi, Kiyonobu Okada, Hajimu Kurumatani, Yoshitaka Mori, Keiyu Oshida, Ikumi Nakajo, Keishi Oikawa, Fumihiko Ushigome, Aiji Miyashita, Masanao Isono, Yohei Miyamoto
The purpose of the present study was to evaluate the pharmacokinetics of beraprost sodium (BPS) and its active enantiomer, BPS-314d, in Japanese subjects with impaired kidney function. The plasma and urine concentrations of BPS and BPS-314d were measured following the single oral administration of 120 μg of BPS as the sustained-release tablet, TRK-100STP, under fasting conditions to 18 subjects with impaired kidney function (stage 2, 3, and 4 chronic kidney disease (CKD) (as categorized by the estimated glomerular filtration rate)) and to 6 age-, body weight-, and gender-matched subjects with normal kidney function (stage 1 CKD)...
September 28, 2016: Journal of Clinical Pharmacology
Raktim K Ghosh, Somedeb Ball, Avash Das, Dhrubajyoti Bandyopadhyay, Samhati Mondal, Debjit Saha, Anjan Gupta
Pulmonary arterial hypertension (PAH) is a relatively rare disease which due to its chronic nature has always been difficult to treat effectively. Selexipag is an oral prostacyclin (PGI2) agonist, which was approved by US Food and Drug Administration (US FDA) in December 2015 for the treatment of PAH. After its success in Phase 1 and Phase 2 clinical trials regarding the convenient oral twice daily dosing and low side-effect profile, selexipag raised the hope of controlling the disease progression in PAH patients...
September 27, 2016: Journal of Clinical Pharmacology
Ernest A Kopecky, Alison B Fleming, Naama Levy-Cooperman, Melinda O'Connor, Edward Sellers
Oxycodone DETERx(®) (Collegium Pharmaceutical Inc, Canton, MA) is an extended-release, microsphere-in-capsule, abuse-deterrent formulation designed to retain its extended-release properties after tampering (eg, chewing/crushing). This randomized, double-blind, placebo-controlled, triple-dummy study evaluated the oral abuse potential of intact and chewed oxycodone DETERx capsules compared with crushed immediate-release oxycodone. Subjects with a history of recreational opioid use who were nondependent/nontolerant to opioids were enrolled...
September 27, 2016: Journal of Clinical Pharmacology
John P Gibbs, J Greg Slatter, Ogo Egbuna, Michelle Geller, Lisa Hamilton, Clapton S Dias, Ren Y Xu, Jessica Johnson, Scott M Wasserman, Maurice G Emery
Evolocumab binds PCSK9, increasing low-density lipoprotein cholesterol (LDL-C) receptors and lowering LDL-C. Target-mediated evolocumab elimination is attributable to PCSK9 binding. As circulating PCSK9 and LDL-C levels are primarily regulated by the liver, we compared evolocumab pharmacokinetics, pharmacodynamics, and safety in individuals with and without hepatic impairment. Open-label, parallel-group study evaluating the pharmacokinetics of evolocumab in hepatic-impaired (Child-Pugh Class A or B) or healthy adults...
September 26, 2016: Journal of Clinical Pharmacology
Wendy Carter, Sarah Connelly, Kimberly Struble
This review paper summarizes the epidemiology of hepatitis C virus (HCV) and chronic HCV infection, including HCV virology and treatment regimens. Specifically we focus on the evolution of past, current and future HCV treatment options, the reasons for treatment failure and the impact of resistance-associated variants on treatment success. This article is protected by copyright. All rights reserved.
September 22, 2016: Journal of Clinical Pharmacology
Tao Liu, Parima Ghafoori, Jogarao V S Gobburu
Pharmacokinetics (PK) plays a key role in bridging drug efficacy and safety from adults to pediatrics. The principal purpose of projecting dosing in pediatrics is to guide trial design, not to waive the study per se. This research was designed to evaluate whether the allometric scaling (AS) approach is a satisfactory method to design PK study in pediatric patients 2 years and older. We systematically evaluated drugs that had pediatrics label information updated from 1998 to 2015. Only intravenous (IV) or oral administration drugs with available PK information in both pediatrics and adults from FDA approved labels were included...
September 21, 2016: Journal of Clinical Pharmacology
Wen Wang, Xiaojing Song, Tong Wang, Chaobin Zhang, Li Sun
The aim of this meta-analysis was to evaluate the preventive efficacy and safety of 5-HT3 receptor antagonists (5-HT3 RAs) on perioperative shivering. Relevant databases were searched to identify eligible randomized, controlled trials through January 2016. Primary outcome was the incidence of perioperative shivering, and secondary outcomes were the incidence of safety-related outcomes including postoperative nausea and vomiting (PONV), bradycardia, and hypotension. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous data...
September 15, 2016: Journal of Clinical Pharmacology
Adriaan Alexander Voors, Hans-Dirk Düngen, Michele Senni, Savina Nodari, Piergiuseppe Agostoni, Piotr Ponikowski, Jeroen J Bax, Javed Butler, Raymond J Kim, Bernard Dorhout, Wilfried Dinh, Mihai Gheorghiade
We studied safety and tolerability of neladenoson bialanate, a novel oral selective partial adenosine A1 receptor agonist that maintains the cardioprotective effects of adenosine without the undesired side effects of a full agonist, in two pilot studies in patients with heart failure with reduced ejection fraction (HFrEF). The β-blocker interaction study was a single blind, placebo controlled study on the effects of a 30 mg single dose of neladenoson bialanate on atrioventricular (AV) conduction in 11 patients with HFrEF treated with β-blockers...
September 14, 2016: Journal of Clinical Pharmacology
C Michael White
This article presents information on illicitly used synthetic cannabinoids. Synthetic cannabinoids are structurally heterogeneous and commonly used drugs of abuse that act as full agonists of the cannabinoid type-1 receptor but have a variety of additional pharmacologic effects. There are numerous cases of patient harm and death in the United States, Europe, and Australia with many psychological, neurological, cardiovascular, pulmonary, and renal adverse events. Although most users prefer using cannabis, there are convenience, legal, and cost reasons driving the utilization of synthetic cannabinoids...
September 9, 2016: Journal of Clinical Pharmacology
Hisham Abdallah, Joy C Hsu, Peng Lu, Scott Fettner, Xiaoping Zhang, Wendy Douglass, Min Bao, Lucy Rowell, Gerd R Burmester, Alan Kivitz
Tocilizumab is a humanized anti-interleukin-6 receptor antibody for treating rheumatoid arthritis. Pharmacokinetic/pharmacodynamic analysis was performed on the 24-week, double-blind parts of 2 randomized controlled trials: SUMMACTA and BREVACTA. SUMMACTA compared subcutaneous tocilizumab 162 mg every week (QW) to intravenous tocilizumab 8 mg/kg every 4 weeks (Q4W), while BREVACTA evaluated 162 mg subcutaneous tocilizumab every 2 weeks (Q2W) versus placebo. In addition to noncompartmental analysis, a two-compartment population pharmacokinetic model, with first-order absorption (for SC) and linear and Michaelis-Menten elimination was used...
September 7, 2016: Journal of Clinical Pharmacology
John M Weiler, Christine A Sorkness, Leslie Hendeles, Yaping Zhu, Sara Nichols
This was a pilot, randomized, double-blind, crossover, proof-of-concept, clinical endpoint study to examine the hypothesis that exhaled nitric oxide (eNO) in asthmatic subjects can demonstrate bioequivalence of fluticasone propionate in Test and Reference combination products. Subjects had ≥6-month history of asthma and screening eNO was ≥60 parts per billion. eNO was ≥55 parts per billion and forced expiratory volume in 1 second (FEV1) was ≥50% predicted, at start of each treatment period. Subjects presented once each consecutive morning in the clinic during each of three weekly treatment periods to measure eNO and receive once-daily doses of 100/50, 250/50, or 500/50 Advair® combination product...
September 1, 2016: Journal of Clinical Pharmacology
Randall Hoover, Thomas C Marbury, Richard A Preston, Megan Quintas, Laura E Lawrence, Susan K Paulson, David R Luke, Sue K Cammarata
Delafloxacin is a novel anionic fluoroquinolone with robust activity against Gram-positive, Gram-negative, atypical, and anaerobic bacteria, including methicillin-resistant S aureus. Delafloxacin is currently being studied for the treatment of acute bacterial skin and skin structure infections and community-acquired pneumonia. This was a phase 1, open-label pharmacokinetic and safety study of a single intravenous dose of 300 mg delafloxacin in subjects with mild, moderate, and severe hepatic impairment (Child-Pugh class A, B, and C, respectively) compared with matched healthy controls...
August 29, 2016: Journal of Clinical Pharmacology
Stephanie Ferreira Botelho, Maria Auxiliadora Parreiras Martins, Liliana Batista Vieira, Ariano Max Moreira Reis
This study investigated post-marketing safety events (PMSE) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSE were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) in the United States Food and Drug Administration (FDA) and Brazil were recorded...
August 29, 2016: Journal of Clinical Pharmacology
Ahmed Hamed Salem, Suresh K Agarwal, Martin Dunbar, Sari L Heitner Enschede, Rod A Humerickhouse, Shekman L Wong
Venetoclax is a selective BCL-2 inhibitor that is now approved in the United States for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior therapy. The aim of this analysis was to characterize venetoclax pharmacokinetics in the plasma and urine of patients with hematological malignancies and evaluate the effect of dose proportionality, accumulation, weak and moderate CYP3A inhibitors as well as low and high fat meals on venetoclax pharmacokinetics...
August 25, 2016: Journal of Clinical Pharmacology
Pierre-Eric Juif, Matthias Hoch, Andrea Vaclavkova, Andreas Krause, Jim Bush, Jasper Dingemanse
Ponesimod, a potent selective sphingosine-1-phosphate receptor 1 modulator, leads to a reduction in circulating total lymphocyte count and transient decreases in heart rate (HR). Based on a modeling and simulation approach, this study was conducted to investigate whether a gradual up-titration regimen may mitigate these cardiodynamic effects. In this double-blind, placebo-controlled, randomized, two-way cross-over study, 32 healthy subjects (15 males) received placebo on Day 1 followed by multiple-dose administration of either ponesimod or placebo (ratio 3:1)...
August 25, 2016: Journal of Clinical Pharmacology
Raymond D Pratt, Dorine W Swinkels, T Alp Ikizler, Ajay Gupta
Ferric pyrophosphate citrate (Triferic) is a water-soluble iron salt that is administered via dialysate to maintain iron balance and hemoglobin in hemodialysis patients. This double-blind, randomized, placebo-controlled, single-, ascending-dose study was conducted to evaluate the pharmacokinetics and safety of intravenous ferric pyrophosphate citrate in 48 healthy iron-replete subjects (drug, n = 36; placebo, n = 12). Single doses of 2.5, 5.0, 7.5, or 10 mg of ferric pyrophosphate citrate or placebo were administered over 4 hours, and single doses of 15 or 20 mg of ferric pyrophosphate citrate or placebo were administered over 12 hours via intravenous infusion...
August 25, 2016: Journal of Clinical Pharmacology
Shruti Agrawal, Paul Statkevich, Gaurav Bajaj, Yan Feng, Sally Saeger, Dharmesh D Desai, Jong-Soon Park, Ian M Waxman, Amit Roy, Manish Gupta
Nivolumab is a fully human IgG4 monoclonal antibody targeting the programmed death-1 (PD-1) receptor that blocks interactions between PD-1 and its ligands on tumor cells to prevent T cell exhaustion in patients with cancer. It has demonstrated efficacy in multiple tumor types including, melanoma, non-small cell lung cancer, and renal cell carcinoma. This analysis assessed the immunogenicity of nivolumab and its impact on pharmacokinetics, safety, and efficacy in patients with solid tumors enrolled in 6 clinical studies...
August 25, 2016: Journal of Clinical Pharmacology
James F Burris, Michael A Tortorici, Maja Mandic, Michael Neely, Michael D Reed
Differences in physiology related to young or old age and/or organ system impairment alter the absorption, distribution, metabolism, and excretion of many medications and consequently their effectiveness and toxicity. This module discusses common alterations in medication use and dosage that are required in the pediatric age group, in the elderly, and in patients with renal or hepatic disease.
August 19, 2016: Journal of Clinical Pharmacology
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