Trial treatment length optimization with an emphasis on disease progression studies.

abstract：:With increasing interest in enrolling adolescent patients in adult trials, a question often arises: when can pediatric patients use adult dosages? For currently approved therapeutic monoclonal antibodies (mAbs) with equivalent adult and pediatric indications, body weight thresholds for pediatric patients to receive ad...

journal_title：Journal of clinical pharmacology

authors： Yang N,Xu MC,Yao Z

更新日期：2019-10-01 00:00:00

abstract：:A prospective study of adverse drug reactions was recently completed at the Clinical Pharmacology Unit of J. J. Group of Hospitals. 338 patients were included in this study, and adverse reactions were noted by a team of workers including a nurse and a physician. World Health Organization definitions were used to descr...

journal_title：Journal of clinical pharmacology

authors： Vakil BJ,Kulkarni RD,Chabria NL,Chadha DR,Deshpande VA

更新日期：1975-05-01 00:00:00

abstract：:T Cell Modulatory Peptide (TCMP-80), L-lysine-L-serine, is a synthetic dipeptide structurally related to a selected amino acid sequence in human immunoglobulin G. Based on in vitro and preclinical in vivo testing, TCMP-80 has immunomodulatory properties. This report describes the first administration of TCMP-80 to man...

journal_title：Journal of clinical pharmacology

authors： Eldon MA,Smith RA,Leese PT,Daigle AE,Katz DV,Richieri SP

更新日期：1990-04-01 00:00:00

abstract：:Trecovirsen, a 25-mer antisense phosphorothioate oligonucleotide targeted at the gag site of the HIV gene, was administered to HIV-positive volunteers as an i.v. infusion. Single doses ranged from 0.1 to 2.5 mg/kg in an ascending escalation in cohorts of 6 to 12 subjects. Plasma trecovirsen concentrations and pharmaco...

journal_title：Journal of clinical pharmacology

authors： Séréni D,Tubiana R,Lascoux C,Katlama C,Taulera O,Bourque A,Cohen A,Dvorchik B,Martin RR,Tournerie C,Gouyette A,Schechter PJ

更新日期：1999-01-01 00:00:00

abstract：:The effect of telbivudine on cardiac repolarization was evaluated in healthy participants at clinical and supratherapeutic doses. Sixty-two participants were enrolled, stratified by sex, and randomized according to a crossover design among 4 treatment sequences: placebo, a single moxifloxacin 400-mg dose as positive c...

journal_title：Journal of clinical pharmacology

authors： Poordad F,Zeldin G,Harris SI,Ke J,Xu L,Mayers D,Zhou XJ

更新日期：2009-12-01 00:00:00

abstract：:The decrease in renal blood flow (RBF) observed in patients with hypertension can be increased with converting enzyme inhibition (CEI). It is unknown whether the decrease in RBF observed with age can also be increased with CEI. This study compared the short- and long-term effects of captopril monotherapy in young (les...

journal_title：Journal of clinical pharmacology

authors： Penner SB,Mitenko PA,Aoki FY,Sitar DS,Smyth DD,McKenzie JK

更新日期：1991-01-01 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 intravenous infusion of cetiedil to a group of ten male volunteers elicited atropine-like side effects on salivation, bronchomotor tone and visual accommodation. With repeated infusions of cetiedil, the incidence as well as the duration of the side effects were reduced significantly, indicating the development of ...

journal_title：Journal of clinical pharmacology

authors： Lewis GP,Cho YW

更新日期：1982-05-01 00:00:00

abstract：:Compared with aminoglycosides, chloramphenicol, sulfonamides, tetracyclines, and even penicillins, the cephalosporins represent a remarkably safe class of antibiotics. Among the cephalosporins, the extended spectrum, third generation agents developed generally produce few side effects and appear to be less allergenic ...

journal_title：Journal of clinical pharmacology

authors： Neu HC

更新日期：1990-05-01 00:00:00

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：:Several approaches are available to estimate the glomerular filtration rate (GFR) from the sinistrin clearance. To compare such approaches, GFR was estimated in six healthy volunteers, both after a bolus injection and a bolus dose followed by a 6-hour infusion. A recently developed high-performance liquid chromatograp...

journal_title：Journal of clinical pharmacology

authors： Buclin T,Pechère-Bertschi A,Séchaud R,Décosterd LA,Munafo A,Burnier M,Biollaz J

更新日期：1997-08-01 00:00:00

abstract：:Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit cyclooxygenase-1 (COX-1), thereby inhibiting platelet function via blockade of thromboxane A2 (TxA2) formation, and COX-2, the enzyme that mediates inflammatory responses. Meloxicam is a relatively COX-2-selective anti-arthritis drug that shows significant TxA2 inh...

journal_title：Journal of clinical pharmacology

authors： Rinder HM,Tracey JB,Souhrada M,Wang C,Gagnier RP,Wood CC

更新日期：2002-08-01 00:00:00

abstract：:After space-flights of less than ten days, orthostatic hypotension upon reentry is characterized by plasma volume depletion that may lead to activation of the Bezold-Jarisch reflex which is also considered to be the mechanism of vasovagal (neurocardiogenic) syncope. For space-flight of longer duration, loss of cardiov...

journal_title：Journal of clinical pharmacology

authors： Piwinski SE,Jankovic J,McElligott MA

更新日期：1994-05-01 00:00:00

abstract：:The availability of poisoning information from the pharmaceutical industry was evaluated. Manufacturers of the top 50 drugs were surveyed. Information that was received was classified by established criteria for evaluation. Compendia on poisoning information was evaluated based on 11 components ranging from toxicity i...

journal_title：Journal of clinical pharmacology

authors： Bolger PB,Shimomura SK,Cupit GC,Davis LJ,McCart GM

更新日期：1979-02-01 00:00:00

abstract：:In ten patients (age: 47-59 yr) with moderately severe essential hypertension, the humoral and hemodynamic effects of a 4-day therapy with 2 x 75 micrograms clonidine, 2 x 20 mg nifedipine (slow-release), and their combination were investigated and compared with baseline values. The following measurements were observe...

journal_title：Journal of clinical pharmacology

authors： Mitrovic V,Patyna W,von Bruchhausen V,Hüting J,Schlepper M

更新日期：1991-06-01 00:00:00

abstract：:Advances in microcomputer technology provide new ways of incorporating PBL procedures in clinical pharmacology courses. Developments in graphics-user interfaces and analog/digital systems that display physiologic information directly on the monitor enable the computer to serve as a learning resource as laboratory clas...

journal_title：Journal of clinical pharmacology

authors： Hutcheon DE,el-Gawly HW

更新日期：1991-03-01 00:00:00

abstract：:The alpha 1-adrenoceptor antagonists doxazosin and terazosin and the 5 alpha-reductase inhibitor finasteride are used in the treatment of benign prostatic hyperplasia. The aim of this study was to assess the potential pharmacokinetic interaction of doxazosin or terazosin when coadministered with finasteride. This was ...

journal_title：Journal of clinical pharmacology

authors： Vashi V,Chung M,Hilbert J,Lawrence V,Phillips K

更新日期：1998-11-01 00:00:00

abstract：:Cyclophosphamide-based regimens are front-line treatment for numerous pediatric malignancies; however, current dosing methods result in considerable interpatient variability in tumor response and toxicity. In this pediatric population, the authors' objectives were (1) to quantify and explain the pharmacokinetic variab...

journal_title：Journal of clinical pharmacology

authors： McCune JS,Salinger DH,Vicini P,Oglesby C,Blough DK,Park JR

更新日期：2009-01-01 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 objectives of the 3 phase I studies described herein were (1) to compare the pharmacokinetics of gabapentin delivered from a novel gastric-retentive dosage form vs an immediate-release formulation, (2) to assess the dose proportionality of the gastric-retentive extended-release formulation, and (3) to determine th...

journal_title：Journal of clinical pharmacology

authors： Chen C,Cowles VE,Hou E

更新日期：2011-03-01 00:00:00

abstract：:Suvorexant is an orexin receptor antagonist for treating insomnia. The maximum approved dose in the United States and Japan is 20 mg. We evaluated suvorexant effects on respiration during sleep in a randomized, double-blind, 3-period crossover study of healthy adult men (n = 8) and women (n = 4) ≤ 50 years old who rec...

journal_title：Journal of clinical pharmacology

authors： Uemura N,McCrea J,Sun H,Donikyan M,Zammit G,Liu R,Louridas B,Marsilio S,Lines C,Troyer MD,Wagner J

更新日期：2015-10-01 00:00:00

abstract：:The antipyretic activity of ibuprofen (Brufen) and paracetamol (Crocin) was compared in 22 children with pyrexia who received either ibuprofen or paracetamol in syrup form. Both axillary and rectal temperatures were recorded prior to drug administration and 1/2, 1, 2, 3, 4, 5, 6, 8, and 12 hours after dosing. Analysis...

journal_title：Journal of clinical pharmacology

authors： Sheth UK,Gupta K,Paul T,Pispati PK

更新日期：1980-11-01 00:00:00

abstract：:Pentoxifylline, a nonselective phosphodiesterase inhibitor, has immunomodulatory activity in vitro and in vivo and potentiates the suppressive effects of glucocorticoids and cyclosporine on lymphocyte proliferation in vitro. Since phosphodiesterase isotypes 3 and 4 predominate in lymphocytes, the authors measured the ...

journal_title：Journal of clinical pharmacology

authors： Briggs WA,Wu Q,Orgul O,Choi M,Scheel PJ Jr,Burdick J

更新日期：1999-08-01 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：: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：:The analgesic efficacy of 100 and 200 mg isoxepac was compared with that of 50 mg indomethacin in a double-blind, single-dose, between-patient (parallel) study with placebo control. Oral doses were administered to 120 patients whose postoperative plan justified administration of analgesics on the morning of the day fo...

journal_title：Journal of clinical pharmacology

authors： Honig WJ,Pelgrom R,Chadha DR

更新日期：1982-02-01 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：:The effectiveness of naproxen in the management of acute gouty arthritis was assessed in an open study of 20 patients. These patients were selected on the basis of their clinical presentation of characteristic acute arthritis associated in 19 with concomitant hyperuricemia. There were 17 men and three women varying in...

journal_title：Journal of clinical pharmacology

authors： Willkens RF,Case JB,Huix FJ

更新日期：1975-04-01 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：: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