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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：:Retigabine, a first-in-class selective M-current potassium channel opener, is a novel antiepileptic compound currently in clinical development. The purpose of this randomized placebo-controlled study was to assess retigabine oral safety and pharmacokinetics in healthy male volunteers (N = 45). Subjects received one do...

journal_title：Journal of clinical pharmacology

authors： Ferron GM,Paul J,Fruncillo R,Richards L,Knebel N,Getsy J,Troy S

更新日期：2002-02-01 00:00:00

abstract：:This trial was conducted to evaluate the pharmacokinetics and safety of a sodium oxybate (gamma-hydroxybutyrate [GHB]) oral solution in narcoleptic patients after acute and chronic treatment. An open-label, two-period, two-treatment study design was used. Trial subjects included 13 patients with polysomnographically c...

journal_title：Journal of clinical pharmacology

authors： Borgen LA,Okerholm RA,Lai A,Scharf MB

更新日期：2004-03-01 00:00:00

abstract：:The electrocardiographic (ECG) effects of rivastigmine treatment were assessed in mild to moderately severe Alzheimer's disease (AD) by analysis of four 26-week, double-blind, multicenter, placebo-controlled, phase III clinical trials. Of an initial 2791 patients, 77% completed treatment. Seventy-one percent required ...

journal_title：Journal of clinical pharmacology

authors： Morganroth J,Graham S,Hartman R,Anand R

更新日期：2002-05-01 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：:Using the hot plate test, the potency and mechanism of the analgesic activity of levonantradol was studied in mice. Levonantradol is 10 to 30 times more potent than morphine; the antinociception can be only partially blocked by naloxone. Similar limited antagonism by cholinergics indicates possible opiodergic mechanis...

journal_title：Journal of clinical pharmacology

authors： Jacob JJ,Ramabadran K,Campos-Medeiros M

更新日期：1981-08-01 00:00:00

abstract：:Quazepam is a new benzodiazepine that may provide good hypnotic action with negligible effect on motor coordination or respiration. Sleep laboratory studies on human volunteers have shown quazepam 15 mg to be an effective hypnotic dose, with the 30-mg dose being optimal. At these doses, there was no deterioration of m...

journal_title：Journal of clinical pharmacology

authors： Murray A,Bellville JW,Comer W,Danielson L

更新日期：1987-04-01 00:00:00

abstract：:A double-blind, placebo-controlled, multiple oral dose escalation study was conducted to investigate the pharmacokinetics, safety, and tolerability of entecavir in healthy subjects. Eight subjects were assigned to each of the 3 dose panels (0.1 mg, 0.5 mg, and 1 mg or matched placebo once daily for 14 days). Blood and...

journal_title：Journal of clinical pharmacology

authors： Yan JH,Bifano M,Olsen S,Smith RA,Zhang D,Grasela DM,LaCreta F

更新日期：2006-11-01 00:00:00

abstract：:Concentrations of diazepam (DZ) and desmethyldiazepam (DMDZ) were determined quantitatively in the brain, skeletal muscle, heart, liver, lung, fat, adrenal gland, and kidney in 14 autopsied patients who had been treated with DZ or clorazepate (a DMDZ prodrug) during their hospital course. To facilitate interpatient co...

journal_title：Journal of clinical pharmacology

authors： Friedman H,Ochs HR,Greenblatt DJ,Shader RI

更新日期：1985-11-01 00:00:00

abstract：:The relationship between indenolol (an investigational agent) plasma levels and the drug's effect on blood pressure and heart rate was investigated after single and repeated once daily administration at two dosage levels (60 mg and 120 mg) in two different groups of patients with first or second stage hypertension, ac...

journal_title：Journal of clinical pharmacology

authors： Sega R,Mailland F,Colombo F,Groothold G,Pantarotto C,Guenzati G,Libretti A

更新日期：1985-07-01 00:00:00

abstract：:Tafenoquine is being developed for relapse prevention in Plasmodium vivax malaria. This Phase I, single-blind, randomized, placebo- and active-controlled parallel group study investigated whether tafenoquine at supratherapeutic and therapeutic concentrations prolonged cardiac repolarization in healthy volunteers. Subj...

journal_title：Journal of clinical pharmacology

authors： Green JA,Patel AK,Patel BR,Hussaini A,Harrell EJ,McDonald MJ,Carter N,Mohamed K,Duparc S,Miller AK

更新日期：2014-09-01 00:00:00

abstract：:Although glucocorticoids and cyclosporine are frequently used to treat patients with various types of glomerulopathy, clinical responses to treatment vary considerably. Considerable interindividual heterogeneity in the suppressive effects of glucocorticoids on lymphocyte proliferation in vitro has been previously repo...

journal_title：Journal of clinical pharmacology

authors： Briggs WA,Gao ZH,Xing JJ,Gimenez LF,Samaniego MD,Scheel PJ,Choi MJ,Burdick JF

更新日期：1996-10-01 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：:The objective of this study was to investigate the influence of food on the pharmacokinetics of tolterodine, its active 5-hydroxymethyl metabolite (5-HM), and exposure to the active moiety (sum of unbound tolterodine + 5-HM) in healthy volunteers. Serum concentrations of tolterodine and 5-HM were measured for up to 12...

journal_title：Journal of clinical pharmacology

authors： Olsson B,Brynne N,Johansson C,Arnberg H

更新日期：2001-03-01 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：:The pharmacokinetics and pharmacodynamics of flunisolide were studied in healthy volunteers after inhalation. In the morning on the day the study began, volunteers inhaled 0.5 mg of flunisolide with and without oral administration of charcoal, or 1 mg, 2 mg, and 3 mg of flunisolide with concomitant administration of c...

journal_title：Journal of clinical pharmacology

authors： Möllmann H,Derendorf H,Barth J,Meibohm B,Wagner M,Krieg M,Weisser H,Knöller J,Möllmann A,Hochhaus G

更新日期：1997-10-01 00:00:00

abstract：:To assess the efficacy and time-dependent effects of once-daily moexipril, a nonsulfhydryl ester prodrug of the angiotensin-converting enzyme (ACE) inhibitor, moexiprilat, we conducted a multicenter, double-blind, placebo-controlled trial in 51 hypertensive patients using both clinic and ambulatory blood pressure (BP)...

journal_title：Journal of clinical pharmacology

authors： White WB,Whelton A,Fox AA,Stimpel M,Kaihlanen PM

更新日期：1995-03-01 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：:The effects of large doses of anabolic steroids on 24-hour blood pressure, cardiac structure and function, and lipid profiles were studied in 10 body builders using anabolic steroids and 14 body builders who did not use steroids (control subjects). All subjects underwent noninvasive 24-hour blood pressure monitoring, ...

journal_title：Journal of clinical pharmacology

authors： Palatini P,Giada F,Garavelli G,Sinisi F,Mario L,Michieletto M,Baldo-Enzi G

更新日期：1996-12-01 00:00:00

abstract：:The Cardiac Antiarrhythmic Suppression Trial (CAST) showed flecainide and encainide induced excess mortality compared with placebo. Labeling drugs as Class 1C is based on clinical observations, comprising measurements of the electrocardiographic parameters QRS. H-V and J-T intervals and of effective refractory period ...

journal_title：Journal of clinical pharmacology

authors： Vaughan Williams EM

更新日期：1991-02-01 00:00:00

abstract：:The time course, dose frequency schedule, and dose-response relationship of the citraturic response to orally administered potassium citrate was examined in 22 normal volunteers and 21 patients with uric acid or calcium nephrolithiasis. The slow-release (wax matrix) preparation of potassium citrate produced a rapid an...

journal_title：Journal of clinical pharmacology

authors： Pak CY,Skurla C,Brinkley L,Sakhaee K

更新日期：1984-01-01 00:00:00

abstract：:In the Phase I study, the new anthracycline aclacinomycin A was given to 22 advanced cancer patients on a schedule of daily intravenous administration for five days repeated every four weeks. The limiting toxicity was myelosuppression, which was severe at a dose of 30 mg/m2 per day for five days. Platelet nadirs were ...

journal_title：Journal of clinical pharmacology

authors： Woolley PV 3rd,Ayoob MJ,Levenson SM,Smith FP

更新日期：1982-08-01 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：: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：:The pathophysiology of poliomyelitis and the recognition of the "post-polio syndrome" suggest that susceptibility to muscle relaxants of patients previously affected by this disease, may be altered. We compared the effects of d-tubocurarine (dTc), pancuronium (P), and gallamine (G) on two pediatric surgical patient gr...

journal_title：Journal of clinical pharmacology

authors： Gyermek L

更新日期：1990-02-01 00:00:00

abstract：:Triamcinolone acetonide (TCA) is a corticosteroid that is frequently used in the treatment of asthma. After inhalation, TCA can become systemically available when the inhaled formulation is swallowed, causing undesirable systemic effects. A clinical study was conducted to determine the systemic side effects of TCA aft...

journal_title：Journal of clinical pharmacology

authors： Rohatagi S,Hochhaus G,Mollmann H,Barth J,Galia E,Erdmann M,Sourgens H,Derendorf H

更新日期：1995-12-01 00:00:00

abstract：:The objective of this study was to determine the effects of double-strength grapefruit juice on gastric pH and systemic bioavailability of indinavir in HIV-infected subjects receiving indinavir. Fourteen HIV-infected subjects took 800 mg of indinavir with 6 ounces (180 ml) of water or double-strength grapefruit juice....

journal_title：Journal of clinical pharmacology

authors： Shelton MJ,Wynn HE,Hewitt RG,DiFrancesco R

更新日期：2001-04-01 00:00:00

abstract：:The effect of the proton pump inhibitor dexlansoprazole, an enantiomer of lansoprazole, on QT intervals was assessed after oral administration of a modified-release formulation of dexlansoprazole (dexlansoprazole MR). In this randomized, positive-comparator, placebo-controlled, 4-period crossover study, 40 healthy par...

journal_title：Journal of clinical pharmacology

authors： Vakily M,Wu J,Atkinson SN

更新日期：2009-12-01 00:00:00

abstract：:UCN-01 is a protein kinase inhibitor under development as a novel anticancer drug. The initial pharmacologic features in patients were not predicted from preclinical experiments. The distribution volume and the systemic clearance were much lower than those in experimental animals (mice, rats, and dogs), and the elimin...

journal_title：Journal of clinical pharmacology

authors： Fuse E,Kuwabara T,Sparreboom A,Sausville EA,Figg WD

更新日期：2005-04-01 00:00:00

abstract：:The overall response rate (ORR) is a largely adopted outcome measure in early-phase oncology trials. ORR is highly relevant in cancer drug development at the time of deciding whether to move to confirmatory phase 3 trials; moreover, ORR is gaining increasing relevance in fast-track registration procedures. No systemat...

journal_title：Journal of clinical pharmacology

authors： Dello Russo C,Cappoli N,Pilunni D,Navarra P

更新日期：2020-11-26 00:00:00