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Journal of Clinical Pharmacology

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https://www.readbyqxmd.com/read/28425095/psychomotor-tremor-and-proprioceptive-control-problems-in-current-and-former-stimulant-drug-users-an-accelerometer-study-of-heavy-users-of-amphetamine-mdma-and-other-recreational-stimulants
#1
Luke A Downey, Brenda Tysse, Talitha C Ford, Angela C Samuels, Rory P Wilson, Andrew C Parrott
The recreational use of various stimulant drugs has been implicated in the development of movement disorders through dysregulation of the dopaminergic and serotoninergic neurotransmitter systems. The present study investigated psychomotor differences in current and former recreational stimulant drug users compared with nonusing controls. Sixty participants comprised 3 groups: 20 current stimulant drug users (CSUs; 11 men, aged 31.4 ± 9.1 years), 20 former stimulant drug users (FSUs; 5 men, aged 39.1 ± 8.5 years), and 20 nonuser controls (NUCs; 5 men, aged 35...
April 19, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419486/population-pharmacokinetic-analysis-of-bortezomib-in-pediatric-leukemia-patients-model-based-support-for-body-surface-area-based-dosing-over-the-2-to-16-year-age-range
#2
Michael J Hanley, Diane R Mould, Timothy J Taylor, Neeraj Gupta, Kaveri Suryanarayan, Rachel Neuwirth, Dixie-Lee Esseltine, Terzah M Horton, Richard Aplenc, Todd A Alonzo, Xiaomin Lu, Ashley Milton, Karthik Venkatakrishnan
This population analysis described the pharmacokinetics of bortezomib after twice-weekly, repeat-dose, intravenous administration in pediatric patients participating in 2 clinical trials: the phase 2 AALL07P1 (NCT00873093) trial in relapsed acute lymphoblastic leukemia and the phase 3 AAML1031 (NCT01371981) trial in de novo acute myelogenous leukemia. The sources of variability in the pharmacokinetic parameters were characterized and quantified to support dosing recommendations. Patients received intravenous bortezomib 1...
April 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419480/characterization-of-neutropenia-in-advanced-cancer-patients-following-palbociclib-treatment-using-a-population-pharmacokinetic-pharmacodynamic-modeling-and-simulation-approach
#3
Wan Sun, Peter J O'Dwyer, Richard S Finn, Ana Ruiz-Garcia, Geoffrey I Shapiro, Gary K Schwartz, Angela DeMichele, Diane Wang
Neutropenia is the most commonly reported hematologic toxicity following treatment with palbociclib, a cyclin-dependent kinase 4/6 inhibitor approved for metastatic breast cancer. Using data from 185 advanced cancer patients receiving palbociclib in 3 clinical trials, a pharmacokinetic-pharmacodynamic model was developed to describe the time course of absolute neutrophil count (ANC) and quantify the exposure-response relationship for neutropenia. These analyses help in understanding neutropenia associated with palbociclib and its comparison with chemotherapy-induced neutropenia...
April 18, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419483/pharmacokinetic-study-of-intravenous-acetaminophen-administered-to-critically-ill-multiple-trauma-patients-at-the-usual-dosage-and-a-new-proposal-for-administration
#4
Oscar Fuster-Lluch, Pedro Zapater-Hernández, Manuel Gerónimo-Pardo
The pharmacokinetic profile of intravenous acetaminophen administered to critically ill multiple-trauma patients was studied after 4 consecutive doses of 1 g every 6 hours. Eleven blood samples were taken (predose and 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360 minutes postdose), and urine was collected (during 6-hour intervals between doses) to determine serum and urine acetaminophen concentrations. These were used to calculate the following pharmacokinetic parameters: maximum and minimum concentrations, terminal half-life, area under serum concentration-time curve from 0 to 6 hours, mean residence time, volume of distribution, and serum and renal clearance of acetaminophen...
April 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28419462/modeling-and-simulation-of-pivotal-clinical-trials-using-linked-models-for-multiple-endpoints-in-chronic-obstructive-pulmonary-disease-with-roflumilast
#5
Axel Facius, Andreas Krause, Laurent Claret, Rene Bruno, Gezim Lahu
Roflumilast is a selective phosphodiesterase 4 inhibitor (PDE4i) for the treatment of severe chronic obstructive pulmonary disease (COPD). In 2 large phase 3 trials in a broader population of COPD patients (BY217/M2-111, ClinicalTrials.gov: NCT00076089 and BY217/M2-112, ClinicalTrials.gov: NCT00430729), treatment with roflumilast reduced the rate of exacerbations; however, the reduction did not reach statistical significance. Two linked dose-response models for the primary (annualized COPD exacerbation counts) and secondary (change from baseline in forced expiratory volume in 1 second [FEV1 ]) end points were therefore developed to characterize and quantify effect sizes and the patient characteristics influencing them...
April 17, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28398628/population-pharmacokinetics-and-target-engagement-of-natalizumab-in-patients-with-multiple-sclerosis
#6
Kumar Kandadi Muralidharan, Geoffrey Kuesters, Tatiana Plavina, Meena Subramanyam, Daniel D Mikol, Sreeja Gopal, Ivan Nestorov
Natalizumab (humanized immunoglobulin G4 antibody targeting alpha-4 integrins) is a highly efficacious treatment for relapsing-remitting multiple sclerosis (RRMS) that has been in clinical use since 2006. However, natalizumab pharmacokinetic (PK) characteristics and concentration alpha-4 integrin saturation relationships have not been well described in the scientific literature. Therefore, clinical data from 11 studies were pooled and analyzed to characterize the PK and pharmacodynamic (PD) properties of natalizumab in RRMS subjects...
April 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28398604/statins-and-lower-gastrointestinal-conditions-a-retrospective-cohort-study
#7
Michelle Pearlman, Yvonne Covin, Robert Schmidt, Eric M Mortensen, Ishak A Mansi
Several studies have reported constipation, abdominal pain, or diarrhea as common adverse events for statins. Statins are among the most commonly prescribed medications, and the impact on the prevalence of these conditions was rarely studied as main outcomes. The aim of this study is to determine if statin therapy is associated with constipation, abdominal pain, diarrhea, or colitis. This was a retrospective cohort study using a regional military health care data from October 1, 2003, to March 1, 2012. A propensity score-matched cohort of statin users and nonusers was created based on 82 variables...
April 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28398597/results-from-the-first-in-human-study-with-ozanimod-a-novel-selective-sphingosine-1-phosphate-receptor-modulator
#8
Jonathan Q Tran, Jeffrey P Hartung, Robert J Peach, Marcus F Boehm, Hugh Rosen, Heather Smith, Jennifer L Brooks, Gregg A Timony, Allan D Olson, Sheila Gujrathi, Paul A Frohna
The sphingosine-1-phosphate 1 receptor (S1P1R ) is expressed by lymphocytes, dendritic cells, and vascular endothelial cells and plays a role in the regulation of chronic inflammation and lymphocyte egress from peripheral lymphoid organs. Ozanimod is an oral selective modulator of S1P1R and S1P5R receptors in clinical development for the treatment of chronic immune-mediated, inflammatory diseases. This first-in-human study characterized the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ozanimod in 88 healthy volunteers using a range of single and multiple doses (7 and 28 days) and a dose-escalation regimen...
April 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28394442/brivaracetam-an-adjunctive-treatment-for-partial-onset-seizures
#9
REVIEW
John A Kappes, William J Hayes, Joe D Strain, Debra K Farver
Brivaracetam is an analogue of levetiracetam that is Food and Drug Administration-approved for adjunctive treatment of partial-onset seizures in patients 16 years and older. In placebo-controlled trials adjunct brivaracetam demonstrated efficacy in reducing the frequency of seizures. The most commonly reported adverse effects are somnolence, dizziness, and fatigue. Clinical trials have evaluated brivaracetam for safety and efficacy in adjunctive treatment of partial-onset seizures in patients 16 years and older for up to 16 weeks...
April 10, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28394418/population-based-pharmacokinetic-and-exposure-efficacy-analyses-of-peginterferon-beta-1a-in-patients-with-relapsing-multiple-sclerosis
#10
Xiao Hu, Yaming Hang, Yue Cui, Jie Zhang, Shifang Liu, Ali Seddighzadeh, Aaron Deykin, Ivan Nestorov
Peginterferon beta-1a reduced annualized relapse rate as compared with placebo and was approved to treat multiple sclerosis patients. A population pharmacokinetic and an exposure-efficacy model were developed to establish the quantitative relationship between pharmacokinetics and annualized relapse rate. The pharmacokinetics was well described by a 1-compartment model with first-order absorption and linear elimination kinetics. Body mass index was the most significant covariate that impacted both clearance and volume of distribution, which in turn impacted area under the curve and maximum serum concentration...
April 10, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28394405/modeling-pharmacokinetic-profiles-of-insulin-regimens-to-enhance-understanding-of-subcutaneous-insulin-regimens
#11
Lai San Tham, Karen Schneck, Ali Ertekin, Jesus Reviriego
Insulin pharmacokinetics following subcutaneous administration were modeled, simulated, and displayed through an interactive and user-friendly interface to illustrate the time course of administered insulins frequently prescribed, providing a simple tool for clinicians through a straightforward visualization of insulin regimens. Pharmacokinetic data of insulin formulations with different onset and duration of action from several clinical studies, including insulin glargine, regular insulin, neutral protamine Hagedorn (NPH), insulin lispro, and premixed preparations of NPH with regular insulin (Mix 70/30), and insulin lispro protamine suspension with insulin lispro (Mix 50/50, Mix 75/25), were used to develop a predictive population pharmacokinetic model of insulins with consideration of factors such as insulin formulation, weight-based dosing, body-weight effect on volume of distribution, and administration time relative to meals, on the insulin time-action profile...
April 10, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28387950/vascular-effects-of-treprostinil-cutaneous-iontophoresis-on-the-leg-finger-and-foot
#12
Florence Gaillard-Bigot, Matthieu Roustit, Jean-François Jourdil, Françoise Stanke-Labesque, Jean-Luc Cracowski
No abstract text is available yet for this article.
April 7, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28387940/the-bial-10-2474-phase-1-study-a-drug-development-perspective-and-recommendations-for-future-first-in-human-trials
#13
REVIEW
Philip Chaikin
BIA 10-2474 (a fatty acid amide hydrolase inhibitor) was evaluated in a first-in-human phase 1 study in normal volunteers to assess safety/tolerability, pharmacokinetics, pharmacodynamics, and food effect. The dose-escalation process consisted of a single-ascending-dose phase (SAD) and multiple-ascending-dose phase (MAD). Prospective determination of the starting dose and maximal escalated dose was consistent with the usual clinical pharmacology principles for extrapolation of preclinical toxicology data to human equivalent doses...
April 7, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28387939/parent-metabolite-pharmacokinetic-modeling-and-pharmacodynamics-of-veliparib-abt-888-a-parp-inhibitor-in-patients-with-brca-1-2-mutated-cancer-or-parp-sensitive-tumor-types
#14
Jing Niu, Christie Scheuerell, Shailly Mehrotra, Sharon Karan, Shannon Puhalla, Brian F Kiesel, Jiuping Ji, Edward Chu, Mathangi Gopalakrishnan, Vijay Ivaturi, Jogarao Gobburu, Jan H Beumer
Veliparib (ABT-888) is a novel oral poly-ADP-ribose polymerase (PARP) inhibitor that is being developed for the treatment of hematologic malignancies and solid tumors. Although the pharmacokinetics of veliparib have been studied in combination with cytotoxic agents, limited information exists regarding the pharmacokinetics (PK) of chronically dosed single-agent veliparib in patients with either BRCA 1/2-mutated cancer or PARP-sensitive tumors. The objectives of the current analysis were to characterize the population pharmacokinetics of veliparib and its primary, active metabolite, M8, and to evaluate the relationship between veliparib and M8 concentrations and poly-ADP-ribose (PAR) level observed in peripheral blood mononuclear cells (PBMCs)...
April 7, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28378883/pharmacokinetics-of-macitentan-in-patients-with-pulmonary-arterial-hypertension-and-comparison-with-healthy-subjects
#15
Milena Issac, Jasper Dingemanse, Patricia N Sidharta
Macitentan is a worldwide approved dual endothelin receptor antagonist that has demonstrated efficacy in the treatment of pulmonary arterial hypertension (PAH) in a phase 3 clinical trial, SERAPHIN, at a dose of 10 mg once daily. During this trial, trough plasma concentrations (Ctrough ) of macitentan and its active metabolite,  ACT-132577,  were obtained at steady state in 242 patients, indicating that mean Ctrough of both analytes was about 2-fold higher in PAH patients than in healthy subjects. To further investigate the pharmacokinetics (PK) of macitentan and its active metabolite, ACT-132577,  a 24-hour PK profile was recorded at steady state in 20 PAH patients in the open-label extension of SERAPHIN...
April 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28378881/antimuscarinic-use-in-females-with-overactive-bladder-syndrome-increases-the-risk-of-depressive-disorder-a-3-year-follow-up-study
#16
Shiu-Dong Chung, Sung-Shun Weng, Chao-Yuan Huang, Herng-Ching Lin, Li-Ting Kao
To date, the relationship between antimuscarinics for overactive bladder (OAB) syndrome and depressive disorder still remains unclear. Therefore, this retrospective cohort study examined the association between antimuscarinic use and the subsequent risk of depressive disorder using a population-based data set. This study used data from the Taiwan Longitudinal Health Insurance Database 2005. We selected 1952 OAB women who received antimuscarinics as the study cohort and 9760 OAB women who did not receive antimuscarinics as the comparison cohort...
April 5, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28369967/a-simulation-study-to-compare-the-treatment-effect-of-tamoxifen-by-cyp2d6-genotypes-and-third-generation-aromatase-inhibitors
#17
Gwan Cheol Park, Jin-A Jung, Kyun-Seop Bae, Hyeong-Seok Lim
Some prospective, randomized clinical trials, including ATAC and BIG 1-98, demonstrated superior treatment effect of third-generation aromatase inhibitors (AIs) versus tamoxifen in postoperative therapy for patients with breast cancer. In retrospective genotyping analyses of the 2 studies using tumor samples, no difference in the treatment effect of tamoxifen was observed by CYP2D6 genotypes. However, those analyses did not consider loss of heterozygosity that could have occurred when genotyping using tumor tissue...
April 3, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28369979/population-pharmacokinetics-of-nusinersen-in-the-cerebral-spinal-fluid-and-plasma-of-pediatric-patients-with-spinal-muscular-atrophy-following-intrathecal-administrations
#18
Kenneth T Luu, Daniel A Norris, Rudy Gunawan, Scott Henry, Richard Geary, Yanfeng Wang
Nusinersen is an antisense oligonucleotide intended for the treatment of spinal muscular atrophy. The pharmacokinetics of nusinersen, following intrathecal administrations, in the cerebrospinal fluid (CSF) and plasma of 72 pediatric patients (3 months to 17 years) with spinal muscular atrophy across 5 clinical trials was analyzed via population-based modeling. With sparse data in the CSF and profile data in the plasma, a linear 4-compartment model simultaneously described the time-concentration profiles in both matrices...
March 29, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28301063/use-of-simvastatin-and-risk-of-acute-pancreatitis-a-nationwide-case-control-study-in-taiwan
#19
Chih-Ming Lin, Kuan-Fu Liao, Cheng-Li Lin, Shih-Wei Lai
The correlation between simvastatin use and acute pancreatitis is explored. A case-control study was conducted to analyze claim data from the Taiwan National Health Insurance Program. The case group comprising a total of 3882 subjects aged 20 to 84 years with their first acute pancreatitis episode occurring between 1998 and 2011 formed the case group, against 3790 randomly selected controls matched for sex, age, comorbidities, and index year of acute pancreatitis diagnosis. Recent use of simvastatin was defined as subjects whose last remaining simvastatin tablet was noted ≤7 days before the date of acute pancreatitis diagnosis...
March 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28273356/population-pharmacokinetic-modeling-of-secukinumab-in-patients-with-moderate-to-severe-psoriasis
#20
Gerard Bruin, Christian Loesche, Judit Nyirady, Oliver Sander
Secukinumab is a human monoclonal antibody with demonstrated efficacy for moderate to severe psoriasis; it binds to and neutralizes interleukin (IL)-17A. The pharmacokinetic (PK) parameters of secukinumab were best described by a 2-compartment model. Only weight was included in the final model, as other covariates did not affect clinical relevance. The estimated serum clearance of secukinumab was 0.19 L/day, with interindividual variability (IIV) of 32% coefficient of variation (CV), and low total volume of distribution (central compartment volume, 3...
March 8, 2017: Journal of Clinical Pharmacology
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