A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

abstract：:1. A bicycle exercise test was used to investigate functional capability and haemodynamics in 30 patients with heart failure (13 NYHA Class II, 17 Class III), before and after i.v. xamoterol (Corwin, Carwin, Corwil, Xamtol, ICI 118,587) 0.2 mg kg-1. 2. Resting heart rate fell from 78 to 74 beats min-1 (P less than 0.0...

journal_title：British journal of clinical pharmacology

authors： Virk SJ,Davies MK

更新日期：1989-01-01 00:00:00

abstract：AIMS:To compare the onset and duration of action of the new antihistamine levocetirizine with that of the second-generation antihistamine fexofenadine using the Vienna Challenge Chamber (VCC). The latter is an environment where subjects can be exposed to specific aeroallergens in controlled and reproducible conditions ...

journal_title：British journal of clinical pharmacology

authors： Horak F,Zieglmayer PU,Zieglmayer R,Kavina A,Lemell P

更新日期：2005-07-01 00:00:00

abstract：:1 We have given fifteen healthy volunteers single doses of racemic (+/-)-propranolol orally (40 mg) and intravenously (5-10 mg) to find out how large the variation was of the ratio between (-)- and (+)-propranolol plasma levels in relation to that of total levels of propranolol and 4-hydroxypropranolol. 2 Total propra...

journal_title：British journal of clinical pharmacology

authors： Von Bahr C,Hermansson J,Tawara K

更新日期：1982-07-01 00:00:00

abstract：AIMS:The use of nonsteroidal anti-inflammatory drugs (NSAIDs) in patients treated with oral anticoagulants is generally discouraged due to the risk of interactions that could increase the risk of bleeding complications. Available data suggest the NSAID, nabumetone, does not produce such an interaction. We investigated ...

journal_title：British journal of clinical pharmacology

authors： Pardo A,García-Losa M,Fernández-Pavón A,del Castillo S,Pascual-García T,García-Méndez E,Dal-Ré R

更新日期：1999-04-01 00:00:00

abstract：:Both the acute blood pressure lowering and renal effects of the calcium antagonist nicardipine and those after 1 week's treatment were investigated in 10 normotensive volunteers and in 10 patients with mild to moderate essential hypertension. After 1 week of placebo, nicardipine was administered orally for 1 week (20 ...

journal_title：British journal of clinical pharmacology

authors： van Schaik BA,van Nistelrooy AE,Geyskes GG

更新日期：1984-07-01 00:00:00

abstract：:1. The pharmacokinetics of methylprednisolone (MP) were studied in five normal subjects following intravenous doses of 20, 40 and 80 mg methylprednisolone sodium succinate (MPSS) and an oral dose of 20 mg methylprednisolone as 4 x 5 mg tablets. Plasma concentrations of MP and MPSS were measured by both high performanc...

journal_title：British journal of clinical pharmacology

authors： Al-Habet SM,Rogers HJ

更新日期：1989-03-01 00:00:00

abstract：AIMS:To examine the hypothesis that sildenafil, a phosphodiesterase type 5 inhibitor that inhibits cGMP breakdown, could enhance nitric oxide-mediated vasodilation and reverse endothelial dysfunction in chronic smokers. METHODS:Flow-mediated dilation of the brachial artery and forearm postischemic reactive hyperemia (...

journal_title：British journal of clinical pharmacology

authors： Dishy V,Harris PA,Pierce R,Prasad HC,Sofowora G,Bonar HL,Wood AJ,Stein CM

更新日期：2004-02-01 00:00:00

abstract：AIMS:New preventative strategies for stroke are required. One promising strategy is uric acid reduction and xanthine oxidase inhibition with allopurinol. We sought to investigate whether allopurinol improves cerebrovascular reactivity (CVR) following subcortical stroke. METHODS:We performed a randomized, double-blind,...

journal_title：British journal of clinical pharmacology

authors： Dawson J,Quinn TJ,Harrow C,Lees KR,Walters MR

更新日期：2009-11-01 00:00:00

abstract：:1 The effect of an intravenous bolus of labetalol (0.6--1.6 mg/kg body weight) on central and peripheral haemodynamics was studied in nine subjects with essential hypertension and in eleven subjects with chronic renal disease and hypertension. 2 The BP reduction amounting to 20/13 mmHg was entirely due to the lowering...

journal_title：British journal of clinical pharmacology

authors： Bahlmann J,Brod J,Hubrich W,Cachovan M,Pretschner P

更新日期：1979-01-01 00:00:00

abstract：:1. The pharmacokinetics, bioavailability and metabolism of nitrendipine were studied in six healthy volunteers (three females, three males) using [13C4]-nitrendipine as a biological internal standard. In the first study the drug was administered simultaneously by the i.v. [13C4] and p.o. (solution) routes and in a sec...

journal_title：British journal of clinical pharmacology

authors： Mikus G,Fischer C,Heuer B,Langen C,Eichelbaum M

更新日期：1987-11-01 00:00:00

abstract：:The effect of metronidazole, at a dose of 1.2 g daily, on theophylline disposition was studied in 10 healthy adult volunteers. Neither theophylline half-life, volume of distribution nor total body clearance was altered by the anti-microbial. It is concluded that metronidazole does not impair theophylline metabolism de...

journal_title：British journal of clinical pharmacology

authors： Adebayo GI,Mabadeje AF

更新日期：1987-07-01 00:00:00

abstract：:Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiv...

journal_title：British journal of clinical pharmacology

authors： Heinrich M

更新日期：2015-07-01 00:00:00

abstract：:Eleven patients with stable rheumatoid disease (RD) who were receiving regular corticosteroid therapy (CS) were investigated to discover the effect on plasma prednisolone levels of additional therapy with the non-steroidal anti-inflammatory (NSAI) drugs, indomethacin and naproxen. There was a highly significant (P les...

journal_title：British journal of clinical pharmacology

authors： Rae SA,Williams IA,English J,Baylis EM

更新日期：1982-09-01 00:00:00

abstract：WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT:Desmopressin is a known haemostatic agent and is also being used, albeit at lower doses, during the diagnostic work-up of Cushing's syndrome, a condition characterized by excess cortisol concentrations and frequent thromboembolic events. No study has yet evaluated whether admini...

journal_title：British journal of clinical pharmacology

authors： Pecori Giraldi F,Ambrogio AG,Fatti LM,Rubini V,Cozzi G,Scacchi M,Federici AB,Cavagnini F

更新日期：2011-01-01 00:00:00

abstract：AIMS:Flavonoids may affect platelet function by several mechanisms, including antagonism of TxA(2) receptors (TP). These TP are present in many tissues and modulate different signalling cascades. We explored whether flavonoids affect platelet TP signalling, and if they bind to TP expressed in other cell types. METHODS...

journal_title：British journal of clinical pharmacology

authors： Guerrero JA,Navarro-Nuñez L,Lozano ML,Martínez C,Vicente V,Gibbins JM,Rivera J

更新日期：2007-08-01 00:00:00

abstract：:1. An open-label, randomised study was performed to assess the effect of tenidap sodium on the pharmacodynamics and plasma protein binding of warfarin. 2. Fourteen healthy male volunteers received either a single oral dose of 120 mg tenidap sodium or matching placebo capsules from days 11 to 36. A single oral dose of ...

journal_title：British journal of clinical pharmacology

authors： Apseloff G,Wilner KD,Gerber N

更新日期：1995-01-01 00:00:00

abstract：AIMS:To ascertain the effects of the Medicines and Healthcare products Regulatory Agency's (MHRA) safety update in June 2010 on the volume of prescribing of quinine and on indices of quinine toxicity. METHODS:We analysed quarterly primary care total and quinine prescribing data for England and quinine prescribing volu...

journal_title：British journal of clinical pharmacology

authors： Acheampong P,Cooper G,Khazaeli B,Lupton DJ,White S,May MT,Thomas SH

更新日期：2013-12-01 00:00:00

abstract：AIM:We investigated whether moxifloxacin-induced QTc prolongations in Japanese and Caucasian healthy male volunteers were significantly different. METHODS:A two period, randomized, crossover, ICH-E14-compliant thorough QT (TQT) study compared placebo-corrected changes in QTc interval from baseline (ΔΔQTc F) and concen...

journal_title：British journal of clinical pharmacology

authors： Morganroth J,Wang Y,Thorn M,Kumagai Y,Harris S,Stockbridge N,Kleiman R,Shah R

更新日期：2015-09-01 00:00:00

abstract：AIMS:To determine whether a medicine review and education programme influences the compliance and knowledge of older people in general practice. METHODS:Older people taking at least three medicines were randomly allocated to a control or intervention group. Both groups received three visits from a clinical pharmacist:...

journal_title：British journal of clinical pharmacology

authors： Lowe CJ,Raynor DK,Purvis J,Farrin A,Hudson J

更新日期：2000-08-01 00:00:00

abstract：:The effects of bopindolol, a new beta-adrenoceptor blocker, on the exercise tolerance of 12 in-patients, mean age 57 (5 years), with stable angina pectoris and documented coronary artery disease were evaluated. All patients received on 4 different days a single oral dose of bopindolol 0.5 mg, bopindolol 1.0 mg, bopind...

journal_title：British journal of clinical pharmacology

authors： Carboni GP,Scardovi AB,D'Ermo M,Prati PL

更新日期：1991-12-01 00:00:00

abstract：:1. The effect of icatibant (D-Arg-[Hyp3, Thi5, D-Tic7, Oic8] bradykinin) a potent B2-kinin receptor antagonist, was studied on bradykinin-induced vasodilation in the human forearm. 2. Eight healthy normotensive men were studied in a rising dose random-placebo controlled study. Placebo and icatibant (20, 50 and 100 mic...

journal_title：British journal of clinical pharmacology

authors： Cockcroft JR,Chowienczyk PJ,Brett SE,Bender N,Ritter JM

更新日期：1994-10-01 00:00:00

abstract：:1. The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory (NSAID) analgesics, using an electronic patient diary. Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic...

journal_title：British journal of clinical pharmacology

authors： van Gerven JM,Schoemaker RC,Jacobs LD,Reints A,Ouwersloot-van der Meij MJ,Hoedemaker HG,Cohen AF

更新日期：1996-10-01 00:00:00

abstract：AIM:Omalizumab, a humanized IgG monoclonal antibody that binds to human immunoglobulin E (IgE), interrupts the allergic cascade in asthmatic patients. The aim was to compare simultaneously drug exposure and IgE biomarker responses in Japanese and White patient populations. METHODS:An instantaneous equilibrium drug-lig...

journal_title：British journal of clinical pharmacology

authors： Hayashi N,Tsukamoto Y,Sallas WM,Lowe PJ

更新日期：2007-05-01 00:00:00

abstract：:The thermogenic beta 3-adrenoceptor agonist BRL 26830A has been shown to increase weight loss in dieting subjects but tremor was a frequent adverse effect. We have investigated the magnitude and nature of this tremor after a single oral dose in 18 subjects. Two complementary techniques were used to attach the recordin...

journal_title：British journal of clinical pharmacology

authors： Connacher AA,Lakie M,Powers N,Elton RA,Walsh EG,Jung RT

更新日期：1990-10-01 00:00:00

abstract：:Twelve patients with acute uncomplicated falciparum malaria were admitted to the Hospital for Tropical Diseases for 42 days. The patients were treated with halofantrine 500 mg 6 hourly for three doses and halofantrine and its desbutyl metabolite were analysed in plasma by h.p.l.c. Cmax values of halofantrine and desbu...

journal_title：British journal of clinical pharmacology

authors： Karbwang J,Milton KA,Na Bangchang K,Ward SA,Edwards G,Bunnag D

更新日期：1991-04-01 00:00:00

abstract：AIMS:The present pharmacokinetic study was undertaken to determine the dose proportionality of three different doses of budesonide-400 microg, 800 microg or 1600 microg administered twice daily by a dry-powder inhaler (Turbuhaler ) in adult patients with mild asthma. METHODS:A total of 38 patients received budesonide ...

journal_title：British journal of clinical pharmacology

authors： Kaiser H,Aaronson D,Dockhorn R,Edsbäcker S,Korenblat P,Källén A

更新日期：1999-09-01 00:00:00

abstract：:1. The beta-adrenergic blocking potencies of practolol, ICI 66082, tolamolol, acebutolol, H 93/26, H 87/07, pindolol and Ro 3-4787 were compared with that of propranolol, on human and rat adipocytes. 2. A good correlation was found between the potencies on adipocytes of the two species but not between our results and ...

journal_title：British journal of clinical pharmacology

authors： Harms HH,Van der Meer J

更新日期：1975-08-01 00:00:00

abstract：:WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT Reflux oesophagitis is a common clinical disorder associated with significant morbidity. Proton pump inhibitors are the current pharmacotherapy of choice, but not all treated patients achieve symptom relief. Little is known about the efficacy of mosapride, a prokinetic agent wh...

journal_title：British journal of clinical pharmacology

authors： Hsu YC,Yang TH,Hsu WL,Wu HT,Cheng YC,Chiang MF,Wang CS,Lin HJ

更新日期：2010-08-01 00:00:00

abstract：:1. The pharmacokinetics of streptokinase (SK) and anistreplase in conventional dosage regimens of 1.5 x 10(6) i.u. of SK infused over 60 min and 30 units of anistreplase over 5 min were studied in 24 consecutive patients presenting with acute myocardial infarction, using a functional bioassay to assess concentrations....

journal_title：British journal of clinical pharmacology

authors： Gemmill JD,Hogg KJ,Burns JM,Rae AP,Dunn FG,Fears R,Ferres H,Standring R,Greenwood H,Pierce D

更新日期：1991-02-01 00:00:00

abstract：:1. Effects of 3 h infusions of adrenaline (0.4 nmol kg-1 min-1) or placebo and of mental stress evoked by a colour word test (CWT) on adrenergic receptor function were investigated in healthy men. Responses of heart rate, blood pressure, plasma catecholamines, plasma cyclic AMP and plasma free fatty acids (FFA) were e...

journal_title：British journal of clinical pharmacology

authors： Larsson PT,Martinsson A,Olsson G,Hjemdahl P

更新日期：1989-12-01 00:00:00