abstract：:Categorizations of best response observed at week 8 (between week 3 and 14) of first-line treatment in two studies of bevacizumab plus chemotherapy in Western (878 patients) and Chinese (198 patients) patients with non-small cell lung cancer were assessed together with baseline prognostic factors in multivariate param...

journal_title：Journal of clinical pharmacology

authors： Claret L,Gupta M,Han K,Joshi A,Sarapa N,He J,Powell B,Bruno R

更新日期：2014-03-01 00:00:00

abstract：:The effect of dose and gender on the pharmacokinetics (PK) and pharmacodynamics (PD) of zolpidem after administration of a buffered zolpidem sublingual tablet (ZST; Intermezzo®, Purdue Pharma L.P., Stamford, CT, USA) was evaluated in healthy non-elderly male and female volunteers. Subjects received a single morning do...

journal_title：Journal of clinical pharmacology

authors： Greenblatt DJ,Harmatz JS,Singh NN,Steinberg F,Roth T,Moline ML,Harris SC,Kapil RP

更新日期：2014-03-01 00:00:00

abstract：:Fosamprenavir (FPV) is the phosphate ester prodrug of the HIV-1 protease inhibitor amprenavir (APV). A pediatric population pharmacokinetic model for APV was developed and simulation was used to identify dosing regimens for pediatric patients receiving FPV in combination with ritonavir (RTV) which resulted in concentr...

journal_title：Journal of clinical pharmacology

authors： Barbour AM,Gibiansky L,Wire MB

更新日期：2014-02-01 00:00:00

abstract：:Antiretrovirals may influence methadone exposure in HIV-1-infected patients receiving methadone for opiate addiction. Rilpivirine is a non-nucleoside reverse transcriptase inhibitor for treating HIV-1 infection. In this open-label trial (NCT00744770), 13 HIV-negative volunteers continued on their regular stable methad...

journal_title：Journal of clinical pharmacology

authors： Crauwels HM,van Heeswijk RP,Vandevoorde A,Buelens A,Stevens M,Hoetelmans RM

更新日期：2014-02-01 00:00:00

abstract：:We aim to evaluate the influence of covariates, including cytochrome P450 3A (CYP3A) genetic polymorphisms, on the pharmacokinetics of midazolam (MDZ) in Asian cancer patients, using a population pharmacokinetic approach. Pharmacokinetic data were obtained from 24 adult cancer patients who received an intravenous bolu...

journal_title：Journal of clinical pharmacology

authors： Seng KY,Hee KH,Soon GH,Sapari NS,Soong R,Goh BC,Lee LS

更新日期：2014-02-01 00:00:00

abstract：:Safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ATR-107, a fully human monoclonal anti-IL-21 receptor (IL-21R) antibody, administered as ascending single doses, subcutaneously or intravenously, was evaluated in a placebo-controlled, double-blind trial in healthy subjects. The dose levels were...

journal_title：Journal of clinical pharmacology

authors： Hua F,Comer GM,Stockert L,Jin B,Nowak J,Pleasic-Williams S,Wunderlich D,Cheng J,Beebe JS

更新日期：2014-01-01 00:00:00

abstract：:Bile acid sequestrants can potentially bind to concomitant drugs. Single-dose studies evaluated the effects of colesevelam on the pharmacokinetics of glimepiride, glipizide extended-release (ER), and olmesartan medoxomil. Each study enrolled healthy subjects aged 18-45 years. The olmesartan medoxomil study used a rand...

journal_title：Journal of clinical pharmacology

authors： He L,Wickremasingha P,Lee J,Tao B,Mendell-Harary J,Walker J,Wight D

更新日期：2014-01-01 00:00:00

abstract：:Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin antibiotic. A population pharmacokinetic (PPK) model for ceftaroline was developed in NONMEM® using data from 185 healthy subjects and 92 patients with acute bacterial skin and skin structure infection (ABSSSI). Data from 128 patien...

journal_title：Journal of clinical pharmacology

authors： Van Wart SA,Forrest A,Khariton T,Rubino CM,Bhavnani SM,Reynolds DK,Riccobene T,Ambrose PG

更新日期：2013-11-01 00:00:00

abstract：:Data from five randomized, placebo-controlled, multiple oral dose studies of empagliflozin in patients with type 2 diabetes mellitus (T2DM; N = 974; 1-100 mg q.d.; ≤12 weeks) were used to develop a population pharmacokinetic (PK) model for empagliflozin. The model consisted of two-compartmental disposition, lagged fir...

journal_title：Journal of clinical pharmacology

authors： Riggs MM,Staab A,Seman L,MacGregor TR,Bergsma TT,Gastonguay MR,Macha S

更新日期：2013-10-01 00:00:00

abstract：:The contribution of renal and non-renal clearance toward targeted concentrations and/or effects of therapeutic proteins in nephrotic patients are unknown. This study dissected the contribution of clearance pathways to adalimumab elimination in patients with focal segmental glomerulosclerosis (FSGS). Urine was collecte...

journal_title：Journal of clinical pharmacology

authors： Roberts BV,Susano I,Gipson DS,Trachtman H,Joy MS

更新日期：2013-09-01 00:00:00

abstract：:Antibacterial drugs are among the most common medications used by pregnant women. While medical literature generally defines nitrofurantoin as an antibiotic that is safe for use during the first trimester of pregnancy, new concerns about a possible association between congenital malformations following exposure to nit...

journal_title：Journal of clinical pharmacology

authors： Goldberg O,Koren G,Landau D,Lunenfeld E,Matok I,Levy A

更新日期：2013-09-01 00:00:00

abstract：:Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, approved for second-line therapy for advanced renal cell carcinoma (RCC). Axitinib population pharmacokinetic and pharmacokinetic/pharmacodynamic relationships were evaluated. Using nonlinear mixed effects modelin...

journal_title：Journal of clinical pharmacology

authors： Rini BI,Garrett M,Poland B,Dutcher JP,Rixe O,Wilding G,Stadler WM,Pithavala YK,Kim S,Tarazi J,Motzer RJ

更新日期：2013-05-01 00:00:00

abstract：:GS-9667, a new selective, partial agonist of the A(1) adenosine receptor (AR), may represent an effective therapy for Type 2 diabetes (T2DM) and dyslipidemia via lowering of free fatty acids (FFA). The objectives of the studies were to evaluate the effects of single and multiple doses of GS-9667 on plasma FFA concentr...

journal_title：Journal of clinical pharmacology

authors： Staehr PM,Dhalla AK,Zack J,Wang X,Ho YL,Bingham J,Belardinelli L

更新日期：2013-04-01 00:00:00

abstract：:Epoxieicosatrienoic acids (EETs) play a protective role against damaging processes in the kidney. We have assessed the effect of polymorphisms in EETs-producing enzymes (CYP2C8 and CYP2J2) and other proteins involved in calcineurin inhibitors (CNIs) disposition (CYP3A4, CYP3A5, and ABCB1) on graft function and clinica...

journal_title：Journal of clinical pharmacology

authors： Gervasini G,Garcia M,Macias RM,Benitez J,Caravaca F,Cubero JJ

更新日期：2013-04-01 00:00:00

abstract：:A randomized, single-blind, placebo-controlled, parallel-group study was conducted to assess the effect of age and gender on the pharmacokinetics and pharmacodynamics of rivaroxaban - an oral, direct Factor Xa inhibitor. Subjects (n = 34) were enrolled into four groups: young males or females (aged 18-45 years) and el...

journal_title：Journal of clinical pharmacology

authors： Kubitza D,Becka M,Roth A,Mueck W

更新日期：2013-03-01 00:00:00

abstract：:Relationships between tocilizumab exposure and response were evaluated using data from 4 phase III studies. Increased tocilizumab exposure was associated with improvements in Disease Activity Score using 28 joints (DAS28) and American College of Rheumatology (ACR) criteria and with a decrease in inflammation markers. ...

journal_title：Journal of clinical pharmacology

authors： Levi M,Grange S,Frey N

更新日期：2013-02-01 00:00:00

abstract：:Adherence to microbicide gel use is critical to optimizing effectiveness in preventing human immunodeficiency virus transmission. The authors hypothesized that ester taggants added to vaginal gels would generate exhaled alcohol and ketone metabolites and provide a "breath test" for vaginal gel use. This 2-arm (vaginal...

journal_title：Journal of clinical pharmacology

authors： Morey TE,Wasdo S,Wishin J,Quinn B,van der Straten A,Booth M,Gonzalez D,Derendorf H,Melker RJ,Dennis DM

更新日期：2013-01-01 00:00:00

abstract：:This study determined the pharmacokinetics (PK) of figitumumab and its effects on insulin-like growth factor (IGF) axis-related biomarkers, following a single intravenous dose (10 [n = 16] and 20 [n = 12] mg/kg) in healthy adults. Serial blood sampling for PK and biomarkers was conducted up to 84 days postdose. A dose...

journal_title：Journal of clinical pharmacology

authors： Yin D,Sleight B,Alvey C,Hansson AG,Bello A

更新日期：2013-01-01 00:00:00

abstract：:A mechanistic drug-disease model was developed on the basis of a previously published integrated glucose-insulin model by Jauslin et al. A glucokinase activator was used as a test compound to evaluate the model's ability to identify a drug's mechanism of action and estimate its effects on glucose and insulin profiles ...

journal_title：Journal of clinical pharmacology

authors： Jauslin PM,Karlsson MO,Frey N

更新日期：2012-12-01 00:00:00

abstract：:Continuous Holter recordings are often used in thorough QT studies (TQTS), with multiple 10-second electrocardiograms (ECGs) visually selected around predesignated time points. The authors hypothesized that computer-automated ECG selection would reduce within-subject variability, improve study data precision, and incr...

journal_title：Journal of clinical pharmacology

authors： George S,Rodriguez I,Ipe D,Sager PT,Gussak I,Vajdic B

更新日期：2012-12-01 00:00:00

abstract：:This retrospective analysis characterizes rituximab population pharmacokinetics in combination with fludarabine and cyclophosphamide and its effect on fludarabine and cyclophosphamide disposition in chronic lymphocytic leukemia (CLL) patients. Rituximab concentration data were well described by a 2-compartment model c...

journal_title：Journal of clinical pharmacology

authors： Li J,Zhi J,Wenger M,Valente N,Dmoszynska A,Robak T,Mangat R,Joshi A,Visich J

更新日期：2012-12-01 00:00:00

abstract：:Lamivudine is a nucleoside reverse transcriptase inhibitor widely used in infants and children in combination antiretroviral therapy to treat human immunodeficiency virus (HIV) infection. Developmental changes in lamivudine pharmacokinetic disposition were assessed by combining data from 7 studies of lamivudine (Pedia...

journal_title：Journal of clinical pharmacology

authors： Tremoulet AH,Nikanjam M,Cressey TR,Chokephaibulkit K,McKinney R,Mirochnick M,Capparelli EV

更新日期：2012-12-01 00:00:00

abstract：:Response to statin therapy is often unpredictable because of variability in metabolism and transport. In the recently created organic anion transporting-polypeptide 1b2 (Oatp1b2/Slco1b2)-null mice, the investigators found significantly lower liver-to-plasma ratios compared with controls for atorvastatin (16.0 ± 5.1 vs...

journal_title：Journal of clinical pharmacology

authors： DeGorter MK,Urquhart BL,Gradhand U,Tirona RG,Kim RB

更新日期：2012-11-01 00:00:00

abstract：:Dienogest offers pharmacological advantages for the effective treatment of endometriosis and for use in contraception and hormone replacement therapy. This pharmacodynamic study investigated the ovulation-inhibiting effects of dienogest monotherapy in healthy women. Dienogest was administered at 0.5, 1, 2, or 3 mg dai...

journal_title：Journal of clinical pharmacology

authors： Klipping C,Duijkers I,Remmers A,Faustmann T,Zurth C,Klein S,Schuett B

更新日期：2012-11-01 00:00:00

abstract：:This study aimed to investigate a food effect on the bio-availability of modified-release (MR) trimetazidine tablets in 36 healthy volunteers. Trimetazidine, an anti-ischemic drug, protects the myocardial cell from the harmful effects of ischemia. The authors investigated the effect of being under a fasting or fed sta...

journal_title：Journal of clinical pharmacology

authors： Ozbay L,Unal DO,Erol D

更新日期：2012-10-01 00:00:00

abstract：:Patients with heart failure (HF) are at increased risk for drug-induced torsades de pointes (TdP) due to unknown mechanisms. Our objective was to determine if sensitivity to drug-induced QT interval lengthening is enhanced in patients with HF. In this multicenter, prospective study, 15 patients with atrial fibrillatio...

journal_title：Journal of clinical pharmacology

authors： Tisdale JE,Overholser BR,Wroblewski HA,Sowinski KM,Amankwa K,Borzak S,Kingery JR,Coram R,Zipes DP,Flockhart DA,Kovacs RJ

更新日期：2012-09-01 00:00:00

abstract：:Armodafinil, the longer lasting R-isomer of racemic modafinil, improves wakefulness in patients with excessive sleepiness associated with shift work disorder (SWD). Pharmacokinetic studies suggest that armodafinil achieves higher plasma concentrations than modafinil late in a dose interval following equal oral doses. ...

journal_title：Journal of clinical pharmacology

authors： Darwish M,Bond M,Ezzet F

更新日期：2012-09-01 00:00:00

abstract：:Mavrilimumab is a fully human monoclonal antibody that binds to granulocyte-macrophage colony stimulating factor receptor α (GM-CSFRα) with high affinity and specificity and has potential application in various inflammatory diseases. The objective of this investigation was to develop a mechanistic population model to ...

journal_title：Journal of clinical pharmacology

authors： Wang B,Lau YY,Liang M,Vainshtein I,Zusmanovich M,Lu H,Magrini F,Sleeman M,Roskos L

更新日期：2012-08-01 00:00:00

abstract：:CS-0777 is a selective sphingosine 1-phosphate receptor-1 (S1P(1)) modulator under development for treatment of autoimmune conditions. A randomized, double-blind, placebo-controlled study was conducted to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of CS-0777 in escalat...

journal_title：Journal of clinical pharmacology

authors： Moberly JB,Rohatagi S,Zahir H,Hsu C,Noveck RJ,Truitt KE

更新日期：2012-07-01 00:00:00

abstract：:It is well known that the CYP2C19 genetic polymorphism influences the pharmacokinetics and pharmacodynamics of proton pump inhibitors (PPIs), but no report has addressed the effects on ilaprazole, a newly developed PPI. To investigate the effects of the CYP2C19 genetic polymorphism on the disposition and pharmacodynam...

journal_title：Journal of clinical pharmacology

authors： Cho H,Choi MK,Cho DY,Yeo CW,Jeong HE,Shon JH,Lee JY,Shin JS,Cho M,Kim DY,Shin JG

更新日期：2012-07-01 00:00:00

abstract：:The effect of bilastine on cardiac repolarization was studied in 30 healthy participants during a multiple-dose, triple-dummy, crossover, thorough QT study that included 5 arms: placebo, active control (400 mg moxifloxacin), bilastine at therapeutic and supratherapeutic doses (20 mg and 100 mg once daily, respectively...

journal_title：Journal of clinical pharmacology

authors： Tyl B,Kabbaj M,Azzam S,Sologuren A,Valiente R,Reinbolt E,Roupe K,Blanco N,Wheeler W

更新日期：2012-06-01 00:00:00

abstract：:Semagacestat, a γ-secretase inhibitor, reduces formation of amyloid beta peptide. Two single-dose (140 mg), open-label, randomized, 3-period, crossover studies evaluated the effect of formulation, food, and time of dosing on the pharmacokinetics and pharmacodynamics of semagacestat in healthy participants. The first s...

journal_title：Journal of clinical pharmacology

authors： Willis BA,Zhang W,Ayan-Oshodi M,Lowe SL,Annes WF,Sirois PJ,Friedrich S,de la Peña A

更新日期：2012-06-01 00:00:00

abstract：:A number of herbal preparations have been shown to interact with prescription medications secondary to modulation of cytochrome P450 (CYP) and/or P-glycoprotein (P-gp). The purpose of this study was to determine the influence of Panax ginseng on CYP3A and P-gp function using the probe substrates midazolam and fexofena...

journal_title：Journal of clinical pharmacology

authors： Malati CY,Robertson SM,Hunt JD,Chairez C,Alfaro RM,Kovacs JA,Penzak SR

更新日期：2012-06-01 00:00:00

abstract：:Rasagiline is an irreversible monoamine oxidase type B (MAO-B) inhibitor indicated for the treatment of the signs and symptoms of idiopathic Parkinson disease as initial monotherapy and as adjunct therapy to levodopa. Pharmacologic inhibition of monoamine oxidase type A (MAO-A), but not MAO-B, poses a risk of the "che...

journal_title：Journal of clinical pharmacology

authors： Chen JJ,Wilkinson JR

更新日期：2012-05-01 00:00:00

abstract：:Aprepitant, a neurokinin antagonist, is an effective antiemetic agent in chemotherapy for delayed nausea and vomiting. The study objective was to evaluate the pharmacokinetics of aprepitant and concurrent cyclophosphamide (CY), often a component of hematopoietic stem cell transplant (HSCT) conditioning regimen, in can...

journal_title：Journal of clinical pharmacology

authors： Bubalo JS,Cherala G,McCune JS,Munar MY,Tse S,Maziarz R

更新日期：2012-04-01 00:00:00

abstract：:The purpose of this analysis was to develop a population pharmacokinetic model for CS-917, an oral hypoglycemic prodrug, and its 3 metabolites. The population pharmacokinetic model was used to predict exposure of the active moiety R-125338 and thus to identify potential CS-917 dosage reduction criteria. The dataset in...

journal_title：Journal of clinical pharmacology

authors： Kastrissios H,Walker JR,Carrothers TJ,Kshirsagar S,Khariton T,Habtemariam B,Mager DE,Rohatagi S

更新日期：2012-03-01 00:00:00

abstract：:Propafenone and its 5-hydroxy metabolite exhibit different electrophysiological properties. Objectives of the CAQ-PAF study were (1) to develop a strategy favoring propafenone instead of 5-hydroxypropafenone in plasma following oral administration of propafenone and (2) to evaluate the potential of low-dose quinidine ...

journal_title：Journal of clinical pharmacology

authors： O'Hara GE,Philippon F,Gilbert M,Champagne J,Michaud V,Charbonneau L,Pruneau G,Hamelin BA,Geelen P,Turgeon J

更新日期：2012-02-01 00:00:00

abstract：:Intravenous amiodarone is an effective agent for the treatment of recurrent ventricular fibrillation and hemodynamically unstable ventricular tachycardia. PM101 Premixed Injection is a new formulation of intravenous amiodarone that uses a cyclodextrin to maintain amiodarone in the aqueous phase. Eighty-eight subjects ...

journal_title：Journal of clinical pharmacology

authors： Cushing DJ,Adams MP,Cooper WD,Agha B,Souney PF

更新日期：2012-02-01 00:00:00

abstract：:Numerous physiologic variations, including urinary protein excretion, low serum albumin concentrations, and reductions in kidney function (clearance), exist in patients with glomerulonephritis. These factors could alter the disposition of numerous drugs. The purpose of the current article was to review the influence o...

journal_title：Journal of clinical pharmacology

authors： Joy MS

更新日期：2012-01-01 00:00:00

abstract：:Aprepitant or its prodrug fosaprepitant, in combination with a corticosteroid and a 5-HT(3) receptor antagonist, are used to prevent chemotherapy-induced nausea and vomiting. This study evaluated the effect of fosaprepitant 150 mg on CYP3A4 metabolism. Fosaprepitant 150 mg has been submitted to regulatory agencies for...

journal_title：Journal of clinical pharmacology

authors： Marbury TC,Ngo PL,Shadle CR,Jin B,Panebianco D,Caro L,Valentine J,Murphy G

更新日期：2011-12-01 00:00:00