Commentary on the FDA draft guidance for bioequivalence studies for nasal aerosols and nasal sprays for local action: an industry view.

abstract：:ABT-335 is the choline salt of fenofibric acid under clinical development as a combination therapy with rosuvastatin for the management of dyslipidemia. ABT-335 and rosuvastatin have different mechanisms of actions and exert complementary pharmacodynamic effects on lipids. The current study assessed the pharmacokineti...

journal_title：Journal of clinical pharmacology

authors： Zhu T,Awni WM,Hosmane B,Kelly MT,Sleep DJ,Stolzenbach JC,Wan K,Chira TO,Pradhan RS

更新日期：2009-01-01 00:00:00

abstract：:This report investigated safety and dosing recommendations of intravenous caspofungin in hepatic insufficiency. In the single-dose study, 8 patients each with mild and moderate hepatic insufficiency received 70 mg of caspofungin. In the multiple-dose study, 8 patients with mild hepatic insufficiency and 13 healthy mat...

journal_title：Journal of clinical pharmacology

authors： Mistry GC,Migoya E,Deutsch PJ,Winchell G,Hesney M,Li S,Bi S,Dilzer S,Lasseter KC,Stone JA

更新日期：2007-08-01 00:00:00

abstract：:This study was undertaken to determine whether rofecoxib can interfere with CYP1A2 activity in humans using theophylline as a probe substrate. Single oral doses of theophylline were administered to each of three panels of 12 healthy subjects receiving daily doses of rofecoxib for 7 days to examine the effect of rofeco...

journal_title：Journal of clinical pharmacology

authors： Bachmann K,White D,Jauregui L,Schwartz JI,Agrawal NG,Mazenko R,Larson PJ,Porras AG

更新日期：2003-10-01 00:00:00

abstract：:To study the pharmacokinetics of single increasing intravenous doses (40-160 mg) and repeated doses (80 mg for 7 days) of lecithinized superoxide dismutase (PC-SOD) in Japanese volunteers and to compare the pharmacokinetics of PC-SOD between Caucasians and Japanese. The Japanese study consisted of 2 parts: a single-do...

journal_title：Journal of clinical pharmacology

authors： Suzuki J,Broeyer F,Cohen A,Takebe M,Burggraaf J,Mizushima Y

更新日期：2008-02-01 00:00:00

abstract：:Therapeutic drug monitoring (TDM) has become standard clinical practice for gentamicin, amikacin, and vancomycin to optimize efficacy and reduce toxicity. TDM after the first dose of antibiotic was adopted in our institution. This study aims to evaluate if target therapeutic drug concentrations could be achieved more ...

journal_title：Journal of clinical pharmacology

authors： Lim WXS,Chua WBB,Chua JM,Lee Q,Chan JW,Sultana R,Poh BH

更新日期：2020-01-01 00:00:00

abstract：:Vitamin B6 has been known to possess antiemetic effects since 1942. This water soluble compound has several forms in the circulation including pyridoxine, pyridoxal, and pyridoxal phosphate. The active antiemetic form of vitamin B6 is unknown. This was a pre-specified substudy of a randomized, placebo-controlled trial...

journal_title：Journal of clinical pharmacology

authors： Matok I,Clark S,Caritis S,Miodovnik M,Umans JG,Hankins G,Mattison DR,Koren G

更新日期：2014-12-01 00:00:00

abstract：:Eleven subjects completed a clinical trial to determine the safety/tolerability of freeze-dried black raspberries (BRB) and to measure, in plasma and urine, specific anthocyanins-cyanidin-3-glucoside, cyanidin-3-sambubioside, cyanidin-3-rutinoside, and cyanidin-3-xylosylrutinoside, as well as ellagic acid. Subjects we...

journal_title：Journal of clinical pharmacology

authors： Stoner GD,Sardo C,Apseloff G,Mullet D,Wargo W,Pound V,Singh A,Sanders J,Aziz R,Casto B,Sun X

更新日期：2005-10-01 00:00:00

abstract：:Cannabichromene (CBC) is one of four major cannabinoids in Cannabis sativa L. and is the second most abundant cannabinoid in drug-type cannabis. Cannabichromene and some of its homologs, analogs, and isomers were evaluated for antiinflammatory, antibacterial, and antifungal activity. Antiinflammatory activity was eval...

journal_title：Journal of clinical pharmacology

authors： Turner CE,Elsohly MA

更新日期：1981-08-01 00:00:00

abstract：:Caffeine has been used frequently in the treatment and prevention of apnea of prematurity. The metabolism of caffeine depends on the activities of the hepatic enzymes that vary from one infant to another. The objective of this study was to determine the influence of postnatal age (PNA), birth weight (BW), study weight...

journal_title：Journal of clinical pharmacology

authors： al-Alaiyan S,al-Rawithi S,Raines D,Yusuf A,Legayada E,Shoukri MM,el-Yazigi A

更新日期：2001-06-01 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：:Ixekizumab (LY2439821), a humanized immunoglobulin G subclass 4 (IgG4) monoclonal antibody that selectively binds and neutralizes interleukin (IL) 17A has demonstrated efficacy in the treatment of psoriasis. A population pharmacokinetics-pharmacodynamics model was developed using NONMEM 7.2 to describe the temporal re...

journal_title：Journal of clinical pharmacology

authors： Tham LS,Tang CC,Choi SL,Satterwhite JH,Cameron GS,Banerjee S

更新日期：2014-10-01 00:00:00

abstract：:Buprenorphine administered sublingually is a promising treatment for opiate dependence. Utilizing a new, sensitive, and specific gas chromatographic electron-capture detector assay, the absolute bioavailability of sublingual buprenorphine was determined in six healthy volunteers by comparing plasma concentrations afte...

journal_title：Journal of clinical pharmacology

authors： Mendelson J,Upton RA,Everhart ET,Jacob P 3rd,Jones RT

更新日期：1997-01-01 00:00:00

abstract：:Thrombomodulin alfa is the recombinant extracellular domain of human thrombomodulin, which shows anticoagulation activity. To elucidate the pharmacokinetics of thrombomodulin alfa in patients with disseminated intravascular coagulation (DIC), population pharmacokinetic (PPK) analysis was performed using plasma concent...

journal_title：Journal of clinical pharmacology

authors： Tsuruta K,Yamada Y,Serada M,Tanigawara Y

更新日期：2011-09-01 00:00:00

abstract：:This report briefly discusses some aspects of autonomic cardiovascular dysfunction as related to changes in orthostatic function in patients, bed rest subjects, and astronauts. This relationship is described in normal individuals to provide the basis for discussion of parameters that may be altered in patients, bed re...

journal_title：Journal of clinical pharmacology

authors： Lathers CM,Charles JB

更新日期：1993-11-01 00:00:00

abstract：:Sixteen healthy male volunteers received a single oral dose of 25 mg doxylamine succinate. Doxylamine concentrations in plasma were measured by a newly developed gas chromatographic methodology, utilizing direct alkaline extraction into hexane:isoamyl alcohol followed by concentration and autoinjection. Doxylamine kin...

journal_title：Journal of clinical pharmacology

authors： Friedman H,Greenblatt DJ

更新日期：1985-09-01 00:00:00

abstract：:The bioavailability and pharmacokinetics of dilevalol following oral and intravenous administration were investigated in 12 healthy male volunteers. Dilevalol HCl was administered as a 200-mg oral tablet and a 50-mg intravenous infusion using a randomized cross-over design. Blood and urine samples were collected over ...

journal_title：Journal of clinical pharmacology

authors： Kramer WG,Nagabhushan N,Affrime MB,Perentesis GP,Symchowicz S,Patrick JE

更新日期：1988-07-01 00:00:00

abstract：:Dual inhibition of neutral endopeptidase 24.11 (NEP) and angiotensin-converting enzyme (ACE) has gained increasing interest in the treatment of hypertension, heart failure, and renoprotection. Specifically, M100240, the thioester of the dual ACE/NEP inhibitor MDL100,173, has been evaluated in the management of hyperte...

journal_title：Journal of clinical pharmacology

authors： Pfister M,Martin NE,Haskell LP,Barrett JS

更新日期：2004-06-01 00:00:00

abstract：:This multicenter, randomized, open-label, parallel-group, phase-1 study assessed the pharmacokinetics (PK), safety, and tolerability of the investigational intramuscular paliperidone palmitate 3-month (PP3M) formulation in patients with schizophrenia or schizoaffective disorder. A total of 328 patients (men or women, ...

journal_title：Journal of clinical pharmacology

authors： Ravenstijn P,Remmerie B,Savitz A,Samtani MN,Nuamah I,Chang CT,De Meulder M,Hough D,Gopal S

更新日期：2016-03-01 00:00:00

abstract：:Type 2 diabetes has now reached epidemic proportions across the world and is the cause of substantial morbidity and mortality. Patients with diabetes suffer from their mircovascular complications of retinopathy (blindness), nephropathy (renal failure, dialysis), and neuropathy (neropathic pain, trophic ulcers). Howeve...

journal_title：Journal of clinical pharmacology

authors： Mudaliar S

更新日期：2004-04-01 00:00:00

abstract：:Food and Drug Administration data show that most anti-depressant studies in youth do not show drug effect. The few positive studies used rigorous diagnostic screening procedures, suggesting major depressive disorder (MDD) may not be a persistent condition in a subgroup of youth. To investigate persistence of MDD, we s...

journal_title：Journal of clinical pharmacology

authors： Malone RP,Bennett DS,Delaney MA,Choudhury MS,Luebbert JF,Cater J

更新日期：2006-09-01 00:00:00

abstract：:The objective of this study was to establish effects of liraglutide on the QTc interval. In this randomized, placebo-controlled, double-blind crossover study, 51 healthy participants were administered placebo, 0.6, 1.2, and 1.8 mg liraglutide once daily for 7 days each. Electrocardiograms were recorded periodically ov...

journal_title：Journal of clinical pharmacology

authors： Chatterjee DJ,Khutoryansky N,Zdravkovic M,Sprenger CR,Litwin JS

更新日期：2009-11-01 00:00:00

abstract：:The population pharmacokinetics of desmopressin in children with nocturnal enuresis and in healthy adults were compared using a 1-compartment model with first-order absorption and first-order elimination. In addition, the model consisted of a number of transit compartments before absorption to describe a lag-time. The...

journal_title：Journal of clinical pharmacology

authors： Osterberg O,Savic RM,Karlsson MO,Simonsson US,Nørgaard JP,Walle JV,Agersø H

更新日期：2006-10-01 00:00:00

abstract：:The confluence of rapid scientific advancements especially in protein engineering and recombinant technology, unmet medical needs, and commercial incentives have led to the development of the next generation of therapeutic proteins. Bispecific antibody constructs are one of the novel strategies that is being pursued, ...

journal_title：Journal of clinical pharmacology

authors： Rathi C,Meibohm B

更新日期：2015-03-01 00:00:00

abstract：:Unresolved issues of ethical, methodological, and legal concerns in the use of normal healthy volunteers persist. Financial incentives in their recruitment offer a unique ethical dilemma because of questions surrounding payment. A review of literature was conducted to obtain research systematically examining volunteer...

journal_title：Journal of clinical pharmacology

authors： Tishler CL,Bartholomae S

更新日期：2002-04-01 00:00:00

abstract：:Tissue pharmacokinetics and plasma protein binding of colistin have not been described in humans in vivo. Colistin concentrations in plasma, muscle, and subcutis of healthy volunteers were measured by microdialysis after a single dose of 2.5 million IU of colistin methanesulfonate. In vitro microdialysis experiments a...

journal_title：Journal of clinical pharmacology

authors： Matzneller P,Gobin P,Lackner E,Zeitlinger M

更新日期：2015-04-01 00:00:00

abstract：:This study was performed to estimate the population pharmacokinetic (PK) parameters of etanercept in pediatric juvenile rheumatoid arthritis (JRA) patients and to compare the steady-state time-concentration profiles between etanercept 0.8-mg/kg once-weekly and 0.4-mg/kg twice-weekly subcutaneous (SC) regimens by clini...

journal_title：Journal of clinical pharmacology

authors： Yim DS,Zhou H,Buckwalter M,Nestorov I,Peck CC,Lee H

更新日期：2005-03-01 00:00:00

abstract：:In a double-blind, placebo-controlled study, an attempt was made to evaluate butaclamol in chronic schizophrenic patients using chlorpromazine (CPZ) as the standard comparative drug. With doses up to 50 mg/day, butaclamol was shown to have significant antipsychotic activity comparable to CPZ but with a much higher inc...

journal_title：Journal of clinical pharmacology

authors： Clark ML,Paredes A,Costiloe JP,Wood F

更新日期：1977-08-01 00:00:00

abstract：:Twenty-three normal volunteers who received morphine sulphate (MS Contin) with naltrexone completed this randomized, analytically blinded, two-way crossover comparison of the bioavailability of one 200-mg oral controlled-release morphine sulfate tablet with two 100-mg MSC tablets. Morphine effects were blocked by thre...

journal_title：Journal of clinical pharmacology

authors： Kaiko RF,Grandy RP,Reder RF,Goldenheim PD,Sackler RS

更新日期：1995-05-01 00:00:00

abstract：:Plasma concentrations of minaxolone were measured in 15 female patients during and for up to 3 hours after a minaxolone and nitrous oxide anesthetic. Nine patients received a single dose and six patients two or three doses of minaxolone. Plasma minaxolone decay can be described by two-compartment kinetics. Distributio...

journal_title：Journal of clinical pharmacology

authors： Dunn GL,Morison DH,McChesney J,Pine W,Kumana CR,Gupta RN

更新日期：1982-07-01 00:00:00

abstract：:Although there are many reports of the short-term effectiveness of antiarrhythmic drugs for suppression of ventricular ectopic depolarizations, there are less data available on the long-term use of these drugs. We treated 122 patients for up to 2 years with antiarrhythmic drugs for suppression of frequent ventricular ...

journal_title：Journal of clinical pharmacology

authors： Salerno DM,Fifield J,Hodges M

更新日期：1990-03-01 00:00:00