Abstract：
OBJECTIVE:In Norway, very little data are available on the relation between the total number of research projects on the clinical development of drugs that have been started, the number of these projects in which the research phase has been completed and the number of projects for which results have been published. The aim of this study was to determine the number of projects in which the research phase had been completed and the results published. MATERIAL AND METHODS:Information on research projects carried out on the clinical development of drugs during the year 2000 was obtained from the archives of the Norwegian Research Ethical Committee (REC) and subsequently analysed. RESULTS:The final analysis revealed that 245 research projects on the clinical development of drugs had been started in 2000. Of these, 178 (73%) completed the research phase as planned. The results of 131 (54%) of these projects were published in a scientific journal, and another 34 (14%) were reported as a congress abstract or as report to a sponsor; 80 (33%) were not published at all. Industrial sponsors seemed to promote both the completion of the research process and the publication of results in scientific journals.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Hole OP,Nitter-Hauge S,Cederkvist HR,Winther FOdoi
10.1007/s00228-008-0601-8subject
Has Abstractpub_date
2009-03-01 00:00:00pages
315-8issue
3eissn
0031-6970issn
1432-1041journal_volume
65pub_type
杂志文章abstract：:The effects of guar gum (GG) and microcrystalline cellulose (MC) on metabolic control and serum lipids were compared in a double-blind, cross-over trial in 18 poorly controlled Type 2 diabetic patients. There were two 12 week treatment periods separated by a 4 week wash-out period. A significant reduction in fasting B...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF00542449
更新日期：1988-01-01 00:00:00
abstract：PURPOSE:Tamsulosin is one of the most potent drugs currently available to treat benign prostatic hyperplasia. Cytochrome P450 (CYP) 2D6 and CYP3A are the two major enzymes responsible for tamsulosin metabolism. The purpose of this study was to evaluate the effects of CYP2D6 and CYP3A5 genetic polymorphisms on the pharm...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-018-2501-x
更新日期：2018-10-01 00:00:00
abstract：:The bronchodilator effects of cumulative doses of terbutaline 0.125 mg, 0.125 mg and 0.250 mg administered as a pressurized aerosol via a pear shaped spacer were compared with those of terbutaline 1.25 mg, 1.25 mg and 2.50 mg administered as a nebulized solution via a PARI-inhaler Boy. FEV1.0 and flow-volume curves in...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF01061373
更新日期：1982-01-01 00:00:00
abstract：:The debrisoquine/sparteine-type polymorphism of drug oxidation and the polymorphism for acetylation are two common inherited variations in human drug metabolism. The phenotypes for hydroxylation and acetylation can be predicted be newly developed methods based on mutation-specific amplification of DNA by the polymeras...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF02220616
更新日期：1992-01-01 00:00:00
abstract：:It is uncertain as to the extent which gastrointestinal (GI) haemorrhage related to NSAIDs is due to a local, topical effect or to an action related to systemic absorption. We hypothesised that, should systemic drug concentrations be of importance, plasma levels of NSAIDs might be higher in patients who had developed ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00316464
更新日期：1993-01-01 00:00:00
abstract：PURPOSE:The existence of a sex-by-formulation interaction in bioequivalence studies implies that the bioequivalence results (i.e., the test/reference ratio of the pharmacokinetic parameters) obtained in one sex are not similar to those obtained in the other sex. Therefore, results obtained in studies including only mal...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/s00228-019-02632-1
更新日期：2019-06-01 00:00:00
abstract：OBJECTIVES:The aims of this study were to examine the effects of genetic and clinical factors on the maintenance dose of tacrolimus in patients following renal transplantation and to develop a tacrolimus-dosing model that could be combined with associated factors. PATIENTS AND METHODS:This study included 142 renal tra...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-011-1010-y
更新日期：2011-08-01 00:00:00
abstract：PURPOSE:The aim of this study was to assess the pharmacokinetics and protein binding of cefazolin in morbidly obese patients undergoing bariatric surgery, to study the influence of bodyweight measures and age on pharmacokinetic parameters and to evaluate unbound cefazolin concentrations over time in this population. M...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-011-1048-x
更新日期：2011-10-01 00:00:00
abstract：:The clearance of chlordiazepoxide from the systemic circulation was studied in 20 subjects which included 15 patients with alcoholic hepatitis and 5 normal volunteers. The half-life for the appearance of the drug in the systemic circulation was found to increase exponentially with age (r = 0.73, P less than 0.0005) an...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00562805
更新日期：1981-03-01 00:00:00
abstract：PURPOSE:In the management of melanoma, BRAF inhibitors yield fast disease control; however, the duration of response does not last very long. Ipilimumab-an anti-CTLA4 antibody on the other hand-provides longer-lasting results of treatment but achieves less favorable responses. The aim of this study was to assess the ef...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-018-2590-6
更新日期：2019-03-01 00:00:00
abstract：:The pharmacokinetics of melatonin during the day-time has been studied in 4 healthy subjects after a bolus i.v. injection of 5 or 10 micrograms/person and after a 5 h infusion of 20 micrograms per person in 6 healthy subjects. In addition, a pinealomectomized patient whose nocturnal plasma melatonin had been abolished...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00315035
更新日期：1990-01-01 00:00:00
abstract：:We have studied the pharmacodynamic effects of ramipril, propranolol, and their combination, as well as the effect of propranolol on the pharmacokinetics of ramipril in 12 healthy men (age 24 (SD 6) y, weight 72 (7) kg). Propranolol and placebo, ramipril and placebo, or propranolol and ramipril were given orally for f...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF00315392
更新日期：1993-01-01 00:00:00
abstract：:Data on forged prescriptions in Sweden in 1982-1986 were studied as an indicator in an epidemiological survey of medication abuse. The annual number of prescription forgeries doubled during the 5-year period. Psychotropic drugs accounted for 62% and analgesics for 25% of all forgeries. Benzodiazepines were the major s...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00637747
更新日期：1989-01-01 00:00:00
abstract：OBJECTIVES:To evaluate zolpidem as a mechanism-based inactivator of human CYP3A in vitro, and to assess its metabolic interaction potential with CYP3A drugs (in vitro-in vivo extrapolation; IV-IVE). METHODS:A co- vs. pre-incubation strategy was used to quantify time-dependent inhibition of human liver microsomal (HLM)...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-009-0760-2
更新日期：2010-03-01 00:00:00
abstract：:The disposition of oral metoprolol was studied in 5 women during the last trimester of pregnancy and 3 to 5 months after delivery. After a single oral dose of 100 mg the individual peak plasma concentration in the pregnant state was only 20-40% of that after pregnancy. The plasma half-lives of metoprolol were about th...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00613820
更新日期：1983-01-01 00:00:00
abstract：:Individual variation in the half-life of caffeine in the body was measured by HPLC analysis of saliva samples. The mean for adult males and non-pregnant females was 3.4 h (range 2-5 h, n = 25), and 8.3 h (range 3-16 h, n = 57) for pregnant women. After delivery, in most cases the values returned to normal within one m...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00637512
更新日期：1981-01-01 00:00:00
abstract：PURPOSE:To correct overdosing of drugs requiring adjustment based on renal function in intensive-care patients. METHODS:In a prospective intervention study, we estimated individual glomerular filtration rate and assessed whether medication required dose adjustment based on renal function. Senior clinicians received a ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-009-0643-6
更新日期：2009-08-01 00:00:00
abstract：:Postural and isometric handgrip tests were performed on nine patients with panic disorder and 13 patients with major depression before and after treatment with imipramine for a mean duration of 10 weeks. There were significant increases in resting supine heart rate (HR), systolic, diastolic and mean blood pressures (S...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00265972
更新日期：1990-01-01 00:00:00
abstract：:The aim of laboratory screening in Phase I is to exclude subjects with subclinical illness, who might be at increased risk in the study, and who might also adversely influence interpretation of the results. A new method for laboratory screening, based on Bayesian probability theory, is proposed, which consists of: 1. ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00280939
更新日期：1990-01-01 00:00:00
abstract：PURPOSE:To quantify the importance of drug-drug interactions (DDIs) in the occurrence of adverse drug reactions (ADRs) reported with serotoninergic reuptake inhibitors in a pharmacovigilance database. METHODS:All spontaneous reports of ADRs registered in 2008 by the Midi-Pyrénées PharmacoVigilance Centre that containe...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-011-1156-7
更新日期：2012-05-01 00:00:00
abstract：:We have studied the pharmacokinetics of fluconazole in five patients on long-term haemodialysis. The single-pass extraction rate of the dialyzer was 59 (3.5)% (n = 4), and the serum concentration was reduced by haemodialysis for 3 or 4 h by 26 (3.2)% (n = 5) and 39 (2.2)% (n = 9) respectively. The estimated amount ext...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00265934
更新日期：1992-01-01 00:00:00
abstract：:The metabolism of hydralazine in a group of slow acetylator patients with the drug-induced lupus syndrome was compared with the metabolism in asymptomatic control subjects. There were no toxicologically significant difference in metabolite excretion between the groups which reached statistical significance, although t...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00556891
更新日期：1984-01-01 00:00:00
abstract：OBJECTIVES:To compare plasma levodopa concentrations after repeated doses of levodopa/carbidopa/entacapone (LCE) and levodopa/carbidopa (LC). METHODS:Open-label, randomized, two-period, active-controlled, cross-over study with four dosing regimens: groups I and II (healthy volunteers and Parkinson's disease patients) ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-009-0622-y
更新日期：2009-05-01 00:00:00
abstract：PURPOSE:The aim of this study was to investigate the contributions of non-genetic and genetic factors on the variability of stable warfarin doses in Thai patients. METHODS:A total of 250 Thai patients with stable warfarin doses were enrolled in the study. Demographics and clinical data, e.g., age, body mass index, ind...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-017-2265-8
更新日期：2017-08-01 00:00:00
abstract：PURPOSE:Perhexiline is a prophylactic anti-ischaemic agent with weak calcium antagonist effect which has been increasingly utilised in the management of refractory angina. The metabolic clearance of perhexiline is modulated by CYP2D6 metaboliser status and stereoselectivity. The current study sought to (1) determine wh...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-015-1934-8
更新日期：2015-12-01 00:00:00
abstract：PURPOSE:The aims of this study were to quantify the behavioural determinants of health professional reporting of medication errors in the United Arab Emirates (UAE) and to explore any differences between respondents. METHODS:A cross-sectional survey of patient-facing doctors, nurses and pharmacists within three major ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-016-2124-z
更新日期：2016-11-01 00:00:00
abstract：PURPOSE:The purpose of this study is to investigate whether there is an association between anticholinergic burden and mortality or rehospitalization in older adults discharged from hospital. METHODS:Prospective multicenter cohort study carried out with patients aged 65 and older discharged from seven acute care hospi...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,多中心研究
doi：10.1007/s00228-017-2312-5
更新日期：2017-11-01 00:00:00
abstract：OBJECTIVE:The aim of this study was to define the pharmacokinetic profile of free carbamazepine (F-CBZ) in adult Omani epileptic patients in order to improve on dosing schedules through population pharmacokinetic analysis using the NONMEM program. METHOD:Steady-state trough F-CBZ serum concentrations, carbamazepine (C...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s002280100300
更新日期：2001-06-01 00:00:00
abstract：OBJECTIVE:The aim of the present study was to evaluate a computerised monitoring system (CMS) based on laboratory test results for the detection of adverse drug reactions (ADRs) on a paediatric ward. METHODS:A prospective, 6-month pharmacoepidemiological survey was performed on a 22-bed paediatric isolation ward. ADRs...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-006-0197-9
更新日期：2006-11-01 00:00:00
abstract：OBJECTIVE:The pharmacokinetics of orally and intravenously administered valsartan were determined in two studies. In a first pilot study, three i.v. doses of valsartan were given in an ascending manner (5, 10 and 20 mg) to evaluate tolerability and basic pharmacokinetics of the i.v. formulation. In a second study, the ...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/s002280050259
更新日期：1997-01-01 00:00:00
