abstract：:A pediatric population pharmacokinetic model including covariate effects was developed using data from 2 clinical trials in pediatric patients with epilepsy (SP0847 and SP1047). Lacosamide plasma concentration-time data (n = 402) were available from 79 children with body weights ranging from 6 to 76 kg, and a balanced...

journal_title：Journal of clinical pharmacology

authors： Winkler J,Schoemaker R,Stockis A

更新日期：2019-04-01 00:00:00

abstract：:Health-related quality of life in people with intellectual disabilities can be affected by challenging behaviors and side effects of antipsychotics. The aim of this study was to evaluate the effect of discontinuation antipsychotic drugs on health-related quality of life, including data from 2 discontinuation trials: a...

journal_title：Journal of clinical pharmacology

authors： Ramerman L,Hoekstra PJ,de Kuijper G

更新日期：2019-02-01 00:00:00

abstract：:Long-term prolactin excess is often accompanied by numerous metabolic complications. No previous study has compared the effect of statin therapy on circulating levels of cardiometabolic risk factors in patients with elevated and normal prolactin levels. The study population consisted of 3 age-, weight-, and lipid-matc...

journal_title：Journal of clinical pharmacology

authors： Krysiak R,Szkróbka W,Okopień B

更新日期：2019-01-01 00:00:00

abstract：:Maraviroc is a C-C chemokine receptor type-5 antagonist approved for the treatment of HIV-1. Previous studies show that cytochrome P450 3A5 (CYP3A5) plays a role in maraviroc metabolism. CYP3A5 is subject to a genetic polymorphism. The presence of 2 functional alleles (CYP3A5*1/*1) confers the extensive metabolism phe...

journal_title：Journal of clinical pharmacology

authors： Vourvahis M,McFadyen L,Nepal S,Valluri SR,Fang A,Fate GD,Wood LS,Marshall JC,Chan PLS,Nedderman A,Haynes J,Savage ME,Clark A,Smith KY,Heera J

更新日期：2019-01-01 00:00:00

abstract：:Nilotinib, an oral inhibitor of the tyrosine kinase activity of Abelson protein, is approved for the treatment of patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase and patients with CML in chronic phase or accelerated phase resistant or intolerant to prior therapies. This review describes t...

journal_title：Journal of clinical pharmacology

authors： Tian X,Zhang H,Heimbach T,He H,Buchbinder A,Aghoghovbia M,Hourcade-Potelleret F

更新日期：2018-12-01 00:00:00

abstract：:This study aimed to evaluate the safety and tolerability of intravenous (IV) levetiracetam (LEV) as a monotherapy in children aged 1 month-16 years and to explore the pharmacokinetics (PK) of IV LEV and the time to seizure after IV then oral administration of LEV in pediatric children with epilepsy. Children diagnosed...

journal_title：Journal of clinical pharmacology

authors： Kim MJ,Yum MS,Yeh HR,Ko TS,Lim HS

更新日期：2018-12-01 00:00:00

abstract：:Few treatments for human diseases have received as much investigation in the past 20 years as probiotics. In 2017, English-language meta-analyses totaling 52 studies determined the effect of probiotics on conditions ranging from necrotizing enterocolitis and colic in infants to constipation, irritable bowel syndrome, ...

journal_title：Journal of clinical pharmacology

authors： Liu Y,Tran DQ,Rhoads JM

更新日期：2018-10-01 00:00:00

abstract：:Effective drug therapy to optimally influence disease requires an understanding of a drug's pharmacokinetic, pharmacodynamic, and pharmacogenomic interrelationships. In pediatrics, age is a continuum that can and does add variability in drug disposition and effect. This article addresses the many important factors tha...

journal_title：Journal of clinical pharmacology

authors： van den Anker J,Reed MD,Allegaert K,Kearns GL

更新日期：2018-10-01 00:00:00

abstract：:Glomerular filtration rate (GFR) is routinely used as a surrogate endpoint for the development of investigational drugs in clinical trials. GFR and staging of chronic kidney disease are typically assessed by measuring the concentration of endogenous serum biomarkers such as albumin and creatinine. However, creatinine ...

journal_title：Journal of clinical pharmacology

authors： Kar S,Paglialunga S,Islam R

更新日期：2018-10-01 00:00:00

abstract：:Respiratory syncytial virus (RSV)-associated respiratory tract infection is a leading cause of hospitalizations in infants for which no effective treatment exists. RSV infection is also an important cause of respiratory disease in adults and immunocompromised patients. Presatovir (GS-5806) is an orally bioavailable an...

journal_title：Journal of clinical pharmacology

authors： German P,Xin Y,Chien JW,Weng W,Mackman R,Lewis SA,Meng A,Ling J,Mathias A

更新日期：2018-08-01 00:00:00

abstract：:A general objective of drug-drug interaction (DDI) studies is to determine whether potential interactions of new molecular entities with concomitantly administered other drugs exist and, if DDIs occur, whether dosage adjustments are required. A typical end point for DDI evaluations is the ratio of area under the plasm...

journal_title：Journal of clinical pharmacology

authors： Yamazaki S

更新日期：2018-08-01 00:00:00

abstract：:The primary objective of this phase 1, open-label, multicenter, 3-period, fixed-sequence study was to evaluate the effect of multiple doses of vemurafenib on the pharmacokinetics of a single dose of digoxin, a probe P-glycoprotein (P-gp) substrate, in patients with BRAFV600 mutation-positive metastatic malignancy. Fol...

journal_title：Journal of clinical pharmacology

authors： Zhang W,McIntyre C,Kuhn M,Forbes H,Kim TM,Lee J,Demidov L,Colburn D

更新日期：2018-08-01 00:00:00

abstract：:The most commonly used Parkinson's disease (PD) treatment is the replacement of dopamine by its levodopa precursor (l-dopa). Monoamine oxidase-B (MAO-B) and catechol-o-methyl transferase (COMT) are enzymes involved in the metabolism and regulation of dopamine availability. In our study we investigated the possible rel...

journal_title：Journal of clinical pharmacology

authors： Sampaio TF,Dos Santos EUD,de Lima GDC,Dos Anjos RSG,da Silva RC,Asano AGC,Asano NMJ,Crovella S,de Souza PRE

更新日期：2018-07-01 00:00:00

abstract：:Despite a robust exposure-response relationship of infliximab in inflammatory bowel disease (IBD), attempts to adjust dosing to individually predicted serum concentrations of infliximab (SICs) are lacking. Compared with labor-intensive conventional software for pharmacokinetic (PK) modeling (eg, NONMEM) dashboards are...

journal_title：Journal of clinical pharmacology

authors： Eser A,Primas C,Reinisch S,Vogelsang H,Novacek G,Mould DR,Reinisch W

更新日期：2018-06-01 00:00:00

abstract：:The aim of this study was to determine the relationship, precision, and bias of a propofol target-controlled infusion (TCI) system during prolonged infusion in neurosurgical patients. We retrospectively included patients undergoing general anesthesia for elective neurosurgical removal of brain tumors and postoperative...

journal_title：Journal of clinical pharmacology

authors： Cortegiani A,Pavan A,Azzeri F,Accurso G,Vitale F,Gregoretti C

更新日期：2018-05-01 00:00:00

abstract：:Current dosing recommendations for rivaroxaban advocate dosage reduction in patients with moderate to severe renal impairment and avoidance of concomitant strong inhibitors of CYP3A or P-glycoprotein. However, rivaroxaban dosing in patients with mild renal impairment taking concomitant moderate inhibitors of CYP3A and...

journal_title：Journal of clinical pharmacology

authors： Ismail M,Lee VH,Chow CR,Rubino CM

更新日期：2018-04-01 00:00:00

abstract：:Pharmacodynamic studies that use methacholine challenge to assess bioequivalence of generic and innovator albuterol formulations are generally designed per published Food and Drug Administration guidance, with 3 reference doses and 1 test dose (3-by-1 design). These studies are challenging and expensive to conduct, ty...

journal_title：Journal of clinical pharmacology

authors： Zeng Y,Singh S,Wang K,Ahrens RC

更新日期：2018-04-01 00:00:00

abstract：:Nintedanib is an intracellular inhibitor of tyrosine kinases used in the treatment of non-small cell lung cancer and idiopathic pulmonary fibrosis (IPF). This phase 1 open-label study investigated the influence of mild and moderate hepatic impairment on the pharmacokinetics (PK), safety, and tolerability of nintedanib...

journal_title：Journal of clinical pharmacology

authors： Marzin K,Kretschmar G,Luedtke D,Kraemer S,Kuelzer R,Schlenker-Herceg R,Schmid U,Schnell D,Dallinger C

更新日期：2018-03-01 00:00:00

abstract：:Traumatic brain injury (TBI) is a major cause of disability and death globally. Despite significant progress in neuromonitoring and neuroprotection, pharmacological interventions have failed to generate favorable results. We examined the effect of memantine on serum levels of neuron-specific enolase (NSE), a marker of...

journal_title：Journal of clinical pharmacology

authors： Mokhtari M,Nayeb-Aghaei H,Kouchek M,Miri MM,Goharani R,Amoozandeh A,Akhavan Salamat S,Sistanizad M

更新日期：2018-01-01 00:00:00

abstract：:The most recent International Conference on Harmonisation E14 Q&A document states that a separate positive control would not be necessary provided sufficiently high exposures are achieved in the early-phase studies. Realistically, a phase 1 study is unlikely to include a pharmacological positive control, and in cases ...

journal_title：Journal of clinical pharmacology

authors： Ferber G,Fernandes S,Täubel J

更新日期：2018-01-01 00:00:00

abstract：:US prescribing guidelines recommend that 15- and 20-mg doses of rivaroxaban be administered with food for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for reduction in the risk of recurrence of DVT and PE. In addition, the US prescribing guidelines recommend these doses be administered w...

journal_title：Journal of clinical pharmacology

authors： Zhang L,Peters G,Haskell L,Patel P,Nandy P,Moore KT

更新日期：2017-12-01 00:00:00

abstract：:Antibody-drug conjugates (ADCs) represent an innovative therapeutic approach that provides novel treatment options and hope for patients with cancer. By coupling monoclonal antibodies (mAbs) to cytotoxic small-molecule payloads with a plasma-stable linker, ADCs offer the potential for increased drug specificity and fe...

journal_title：Journal of clinical pharmacology

authors： Vezina HE,Cotreau M,Han TH,Gupta M

更新日期：2017-10-01 00:00:00

abstract：:Experimental interventions that activate specific components of clinical pain are necessary for characterization of underlying mechanisms and pharmacology. Cutaneous hyperalgesia has been described that uses nonpainful heat to induce secondary hyperalgesia. This study evaluated the effect of intravenous alfentanil on ...

journal_title：Journal of clinical pharmacology

authors： Schifftner C,Schulteis G,Wallace MS

更新日期：2017-09-01 00:00:00

abstract：: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 develo...

journal_title：Journal of clinical pharmacology

authors： Sun W,O'Dwyer PJ,Finn RS,Ruiz-Garcia A,Shapiro GI,Schwartz GK,DeMichele A,Wang D

更新日期：2017-09-01 00:00:00

abstract：:Bococizumab (RN316/PF-04950615), a humanized monoclonal antibody, binds to secreted proprotein convertase subtilisin/kexin type 9 (PCSK9) and prevents its downregulation of low-density lipoprotein receptor, leading to improved clearance and reduction of low-density lipoprotein cholesterol (LDL-C) in plasma. A mechanis...

journal_title：Journal of clinical pharmacology

authors： Udata C,Garzone PD,Gumbiner B,Joh T,Liang H,Liao KH,Williams JH,Meng X

更新日期：2017-07-01 00:00:00

abstract：:To investigate the impact of cytochrome P450 (CYP) genetic polymorphisms CYP2B6, CYP2C19, and CYP3A5 on mRNA expression, cyclophosphamide/4-hydroxycyclophosphamide pharmacokinetics, and treatment outcomes of the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in Chinese patients ...

journal_title：Journal of clinical pharmacology

authors： Shu W,Chen L,Hu X,Zhang M,Chen W,Ma L,Liu X,Huang J,Pang T,Li J,Zhang Y

更新日期：2017-07-01 00:00:00

abstract：:In the pivotal TEMPO 3:4 trial, the arginine vasopressin V2-receptor antagonist tolvaptan reduced the rate of kidney growth in patients with autosomal dominant polycystic kidney disease. Tolvaptan was initiated as daily morning/afternoon doses of 45/15 mg, and uptitrated weekly to 60/30 mg and 90/30 mg according to pa...

journal_title：Journal of clinical pharmacology

authors： Shoaf SE,Chapman AB,Torres VE,Ouyang J,Czerwiec FS

更新日期：2017-07-01 00:00:00

abstract：:Despite a paucity of data, the role of intravenous lidocaine (IVLI) as adjunctive analgesia in the intensive care unit (ICU) seems promising due to a low potential to contribute to respiratory depression. A retrospective chart review was conducted to evaluate the safety and effectiveness of IVLI for the treatment of p...

journal_title：Journal of clinical pharmacology

authors： Mo Y,Thomas MC,Antigua AD,Ebied AM,Karras GE Jr

更新日期：2017-07-01 00:00:00

abstract：: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 (M...

journal_title：Journal of clinical pharmacology

authors： Chaikin P

更新日期：2017-06-01 00:00:00

abstract：:Two phase I open-label studies were conducted to investigate the pharmacokinetics (PK), safety, and tolerability of single oral doses of selumetinib in subjects with end-stage renal disease (ESRD) undergoing hemodialysis and subjects with varying degrees of hepatic impairment; both studies included a matched control g...

journal_title：Journal of clinical pharmacology

authors： Dymond AW,Martin P,So K,Huang Y,Severin P,Holmes V,Mariani G,Marbury T

更新日期：2017-05-01 00:00:00

abstract：: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, an...

journal_title：Journal of clinical pharmacology

authors： Gibbs JP,Slatter JG,Egbuna O,Geller M,Hamilton L,Dias CS,Xu RY,Johnson J,Wasserman SM,Emery MG

更新日期：2017-04-01 00:00:00

abstract：:Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime for the treatment of certain serious Gram-negative infections. As avibactam is primarily excreted unchanged in the urine, renal impairment may affect its pharmacokinetics. This phase 1 study investigated the...

journal_title：Journal of clinical pharmacology

authors： Merdjan H,Tarral A,Das S,Li J

更新日期：2017-02-01 00:00:00

abstract：:The primary objective of the current investigation was to establish the pharmacokinetic characteristics of oxymetazoline and tetracaine's primary metabolite, para-butylaminobenzoic acid (PBBA), after the intranasal administration of oxymetazoline/tetracaine. Thirty-six subjects contributing a total of 1791 plasma conc...

journal_title：Journal of clinical pharmacology

authors： Cacek AT,Gobburu JV,Gopalakrishnan M

更新日期：2017-02-01 00:00:00

abstract：:Current guidelines for hypercholesterolemia treatment emphasize lifestyle modification and lipid-modifying therapy to reduce the risk for cardiovascular disease. Statins are the primary class of agents used for the treatment of hypercholesterolemia. Although statins are effective for many patients, they fail to achiev...

journal_title：Journal of clinical pharmacology

authors： Ito MK,Santos RD

更新日期：2017-01-01 00:00:00

abstract：:Precision medicine in oncology is the result of an increasing awareness of patient-specific clinical features coupled with the development of genomic-based diagnostics and targeted therapeutics. Companion diagnostics designed for specific drug-target pairs were the first to widely utilize clinically applicable tumor b...

journal_title：Journal of clinical pharmacology

authors： Schmidt KT,Chau CH,Price DK,Figg WD

更新日期：2016-12-01 00:00:00

abstract：:We compared the pharmacokinetic (PK) exposure parameters of efavirenz (EFV) and its major inactive metabolite, 8-hydroxy-efavirenz (8-OH-EFV), in an open-label, single-sequence, and parallel design of HIV-infected and tuberculosis (TB)-HIV-coinfected Ethiopian patients in the HIV-TB Pharmagene study with 20 and 33 pat...

journal_title：Journal of clinical pharmacology

authors： Habtewold A,Aklillu E,Makonnen E,Amogne W,Yimer G,Aderaye G,Bertilsson L,Owen JS,Burhenne J

更新日期：2016-12-01 00:00:00

abstract：:Gestational diabetes mellitus (GDM) has affected a great number of pregnant women worldwide. Artemisia extracts have been found to exhibit a potent antidiabetic effect in the treatment of type 2 diabetes mellitus. We aimed to examine the effects of Artemisia extract on insulin resistance and lipid profiles in pregnant...

journal_title：Journal of clinical pharmacology

authors： Sun X,Sun H,Zhang J,Ji X

更新日期：2016-12-01 00:00:00

abstract：:Nintedanib, a triple angiokinase inhibitor, has undergone clinical investigation for the treatment of solid tumors and idiopathic pulmonary fibrosis. Nintedanib (Vargatef® ) plus docetaxel is approved in the EU for the treatment of patients with adenocarcinoma non-small cell lung cancer (NSCLC) after first-line chemot...

journal_title：Journal of clinical pharmacology

authors： Dallinger C,Trommeshauser D,Marzin K,Liesener A,Kaiser R,Stopfer P

更新日期：2016-11-01 00:00:00

abstract：:Udenafil, a cyclic guanosine monophosphate-specific phosphodiesterase type 5 inhibitor, has been developed to treat erectile dysfunction. We evaluated the effect of age on the pharmacokinetics and tolerability of udenafil. A single-center, open-label, parallel-group phase 1 study was conducted in healthy adult subject...

journal_title：Journal of clinical pharmacology

authors： Choi HK,Jung JA,Shon J,Bahng MY,Cho DY,Yeo CW,Kim EY,Shin JG

更新日期：2016-11-01 00:00:00

abstract：:Transporters play an important role in drug absorption, disposition, and drug action. The evaluation of drug transporters requires a comprehensive understanding of transporter biology and pharmacology. Physiologically based pharmacokinetic (PBPK) models may offer an integrative platform to quantitatively evaluate the ...

journal_title：Journal of clinical pharmacology

authors： Pan Y,Hsu V,Grimstein M,Zhang L,Arya V,Sinha V,Grillo JA,Zhao P

更新日期：2016-07-01 00:00:00