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Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/27925676/population-pharmacokinetics-and-exposure-response-relationship-of-carfilzomib-in-patients-with-multiple-myeloma
#1
Ying Ou, Sameer Doshi, Anh Nguyen, Fredrik Jonsson, Sanjay Aggarwal, Kanya Rajangam, Meletios A Dimopoulos, A Keith Stewart, Ashraf Badros, Kyriakos P Papadopoulos, David Siegel, Sundar Jagannath, Ravi Vij, Ruben Niesvizky, Richard Graham, Jenn Visich
A population pharmacokinetic (PK) model and exposure-response (E-R) analysis was developed using data collected from 5 phase 1b/2 and 2 phase 3 studies in subjects with multiple myeloma. Subjects receiving intravenous infusion on 2 consecutive days each week for 3 weeks (days 1, 2, 8, 9, 15, and 16) in each cycle at doses ranging from 15 to 20/56 mg/m(2) (20 mg/m(2) in cycle 1 and, if tolerated, escalated to 56 mg/m(2) on day 8 of cycle 1). The population PK analysis indicated that among all the covariates tested, the only statistically significant covariate was body surface area on carfilzomib clearance; however, this covariate was unlikely to be clinically significant...
December 7, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27925657/population-pharmacokinetics-of-cefazolin-in-serum-and-adipose-tissue-from-overweight-and-obese-women-undergoing-cesarean-delivery
#2
Mordechai Grupper, Joseph L Kuti, Morgan L Swank, Lindsay Maggio, Brenna L Hughes, David P Nicolau
The optimal antibiotic prophylaxis dosing regimen of cefazolin for cesarean delivery (CD) in overweight and obese women is unknown. This study was done to compare the duration that cefazolin concentrations remain above the minimum inhibitory concentration (MIC) in adipose tissue (AT). Serum and AT concentrations from 3 previous studies in CD patients were comodeled using the nonparametric adaptive grid algorithm in Pmetrics. AT concentrations for 5000 overweight and obese patients receiving 1-, 2-, and 3-g cefazolin regimens were simulated to calculate the probability that free drug concentrations remained above an MIC of 2 μg/mL at 1, 1...
December 7, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27925651/model-based-dose-selection-for-intravaginal-ring-formulations-releasing-anastrozole-and-levonorgestrel-intended-for-the-treatment-of-endometriosis-symptoms
#3
Isabel Reinecke, Marcus-Hillert Schultze-Mosgau, Rüdiger Nave, Heinz Schmitz, Bart A Ploeger
Pharmacokinetics (PK) of anastrozole (ATZ) and levonorgestrel (LNG) released from an intravaginal ring (IVR) intended to treat endometriosis symptoms were characterized, and the exposure-response relationship focusing on the development of large ovarian follicle-like structures was investigated by modeling and simulation to support dose selection for further studies. A population PK analysis and simulations were performed for ATZ and LNG based on clinical phase 1 study data from 66 healthy women. A PK/PD model was developed to predict the probability of a maximum follicle size ≥30 mm and the potential contribution of ATZ beside the known LNG effects...
December 7, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27922734/population-pharmacokinetics-of-ceritinib-in-adult-patients-with-tumors-characterized-by-genetic-abnormalities-in-anaplastic-lymphoma-kinase
#4
Ying Hong, Vanessa Q Passos, Pai-Hsi Huang, Yvonne Y Lau
Ceritinib is a second-generation selective and potent oral anaplastic lymphoma kinase (ALK) inhibitor approved for ALK-positive advanced non-small cell lung cancer previously treated with crizotinib. Population pharmacokinetic (PK) analysis was performed to describe the PK of ceritinib and was used to evaluate the covariate effects on systemic exposure at its label dose (750 mg orally once daily). Ceritinib concentration-time data from 4 clinical studies were described by a 1-compartment model with delayed first-order absorption and time-dependent elimination...
December 6, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27922719/markov-mixed-effects-modeling-using-electronic-adherence-monitoring-records-identifies-influential-covariates-to-hiv-preexposure-prophylaxis
#5
Kumpal Madrasi, Ayyappa Chaturvedula, Jessica E Haberer, Mark Sale, Michael J Fossler, David Bangsberg, Jared M Baeten, Connie Celum, Craig W Hendrix
Adherence is a major factor in the effectiveness of preexposure prophylaxis (PrEP) for HIV prevention. Modeling patterns of adherence helps to identify influential covariates of different types of adherence as well as to enable clinical trial simulation so that appropriate interventions can be developed. We developed a Markov mixed-effects model to understand the covariates influencing adherence patterns to daily oral PrEP. Electronic adherence records (date and time of medication bottle cap opening) from the Partners PrEP ancillary adherence study with a total of 1147 subjects were used...
December 6, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27874971/cefiderocol-a-siderophore-cephalosporin-for-gram-negative-bacterial-infections-pharmacokinetics-and-safety-in-subjects-with-renal-impairment
#6
Takayuki Katsube, Roger Echols, Juan Camilo Arjona Ferreira, Heidi K Krenz, Jolene Kay Berg, Christopher Galloway
Cefiderocol, a new injectable siderophore cephalosporin antibiotic, has promising in vitro and in vivo activity against Gram-negative bacteria including multidrug-resistant Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae. Cefiderocol is mainly renally eliminated. The pharmacokinetics and safety of cefiderocol in subjects with renal impairment were assessed following a single 1000-mg intravenous 1-hour infusion of cefiderocol. Subjects with mild, moderate, or severe renal impairment and end-stage renal disease (ESRD) requiring hemodialysis were compared with demographically (age, body mass index, and sex) matched healthy subjects with normal renal function...
November 22, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27868207/extracorporeal-clearance-of-levetiracetam-during-continuous-venovenous-hemofiltration-in-a-critically-ill-patient-and-new-dosing-recommendation
#7
LETTER
Jos L M L le Noble, Norbert A Foudraine, Francois H M Kornips, Davy G H A van Dam, Cees Neef, Paddy K C Janssen
No abstract text is available yet for this article.
November 21, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27859337/exposure-response-analyses-supporting-ticagrelor-dosing-recommendation-in-patients-with-prior-myocardial-infarction
#8
Daniel Röshammar, Joakim Nyberg, Tomas Andersson, Donald Stanski, Robert F Storey, Bengt Hamrén
The relationships between drug exposure and the composite risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke as well as the risk of TIMI major bleeding were estimated following long-term treatment with ticagrelor 60 or 90 mg twice daily in 20,942 patients with prior MI. These analyses support the primary reported efficacy and safety evaluations by showing that there were clear separations from placebo early in treatment with both doses, regardless of ticagrelor exposure, for both endpoints...
November 18, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27861991/impact-of-target-mediated-elimination-on-the-dose-and-regimen-of-evolocumab-a-human-monoclonal-antibody-against-proprotein-convertase-subtilisin-kexin-type-9-pcsk9
#9
John P Gibbs, Sameer Doshi, Mita Kuchimanchi, Anita Grover, Maurice G Emery, Michael G Dodds, Megan A Gibbs, Ransi Somaratne, Scott M Wasserman, Dirk Blom
Understanding the pharmacokinetic (PK) and pharmacodynamic (PD) relationship of a therapeutic monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9) exhibiting target-mediated drug disposition (TMDD) is critical for selecting optimal dosing regimens. We describe the PK/PD relationship of evolocumab using a mathematical model that captures evolocumab binding and removal of unbound PCSK9 as well as reduction in circulating low-density lipoprotein cholesterol (LDL-C). Data were pooled from 2 clinical studies: a single-dose escalation study in healthy subjects (7-420 mg SC; n = 44) and a multiple-dose escalation study in statin-treated hypercholesterolemic patients (14 mg weekly to 420 mg monthly [QM] SC; n = 57)...
November 15, 2016: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27599455/time-trends-in-physician-visits-for-gastroesophageal-reflux-disease-before-and-after-the-rx-to-otc-switch-of-proton-pump-inhibitors
#10
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
https://www.readbyqxmd.com/read/27704554/prediction-of-clearance-in-neonates-and-infants-%C3%A2-3-months-of-age-for-drugs-that-are-glucuronidated-a-comparative-study-between-allometric-scaling-and-physiologically-based-pharmacokinetic-modeling
#11
Iftekhar Mahmood, 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
https://www.readbyqxmd.com/read/27681484/the-pharmacokinetics-of-beraprost-sodium-following-single-oral-administration-to-subjects-with-impaired-kidney-function
#12
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
https://www.readbyqxmd.com/read/27670133/selexipag-in-pulmonary-arterial-hypertension-most-updated-evidence-from-recent-preclinical-and-clinical-studies
#13
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
https://www.readbyqxmd.com/read/27669664/oral-human-abuse-potential-of-oxycodone-deterx-%C3%A2-xtampza-%C3%A2-er
#14
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
https://www.readbyqxmd.com/read/27667740/evaluation-of-evolocumab-amg-145-a-fully-human-anti-pcsk9-igg2-monoclonal-antibody-in-subjects-with-hepatic-impairment
#15
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
https://www.readbyqxmd.com/read/27654843/reinventing-hcv-treatment-past-and-future-perspectives
#16
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
https://www.readbyqxmd.com/read/27649629/allometry-is-a-reasonable-choice-in-pediatric-drug-development
#17
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
https://www.readbyqxmd.com/read/27628928/5-ht3-receptor-antagonists-for-the-prevention-of-perioperative-shivering-a-meta-analysis
#18
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
https://www.readbyqxmd.com/read/27624622/safety-and-tolerability-of-neladenoson-bialanate-a-novel-oral-partial-adenosine-a1-receptor-agonist-in-patients-with-chronic-heart-failure
#19
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 2 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
https://www.readbyqxmd.com/read/27539787/dosage-adjustments-related-to-young-or-old-age-and-organ-impairment
#20
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.
December 2016: Journal of Clinical Pharmacology
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