Abstract:
:An expert meeting to discuss population pharmacokinetic/pharmacodynamic software was held in Brussels in November 1993 under the auspices of the European Co-operation in Science and Technology (COST), Medicine (B1) programme. Recently developed statistical methods offer the possibility of gaining integrated information on pharmacokinetics and response from relatively sparse observational data obtained directly in patients who are being treated with the drug under development. These methods can minimize the need to exclude patient groups and also allow analysis of a variety of unbalanced designs that frequently arise in the evaluation of the relationships between dose or concentration on the one hand and efficacy or safety on the other relationships that do not readily lend themselves to other forms of statistical analysis. The purpose of the Brussels meeting was to evaluate the state of both existing software and software under development, and to specify the needs and wishes of potential users of such software. It was apparent from the meeting that software development for population data analysis is currently a very active area of investigation and that several very good packages are already available, with more in development. The general consensus of the meeting was that well validated, easy to use software was essential to the implementation of the population approach to drug development.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Aarons L,Balant LP,Mentré F,Morselli PL,Rowland M,Steimer JL,Vozeh Sdoi
10.1007/BF00191898subject
Has Abstractpub_date
1994-01-01 00:00:00pages
389-91issue
5eissn
0031-6970issn
1432-1041journal_volume
46pub_type
abstract::Differences in the plasma concentrations of drugs after oral administration are caused by two main factors: variation in absorption ratios and in the distribution processes in the body. A new method for the dissection of both types of factors is discussed. The method uses a reference regression of the AUC-values to th...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00545226
更新日期:1982-01-01 00:00:00
abstract::As a target group, geriataric patients were selected for pharmacokinetic studies with terodiline (Mictrol), an anticholinergic and calcium antagonist drug effective in the treatment of urinary incontinence. The single-dose kinetics in the geriatric patients (mean age 82 years) differed significantly from that previous...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00540958
更新日期:1988-01-01 00:00:00
abstract:OBJECTIVE:Psychotropic drug use among nursing home residents with regard to diagnostic indications and patient- and institution characteristics was analysed. METHODS:A cross-sectional study of medication data from 1552 residents at 23 nursing homes in Bergen, Norway, was performed. Psychotropic drug use (neuroleptics,...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280100348
更新日期:2001-09-01 00:00:00
abstract::The diabetogenic effect of deflazacort (DF), an oxazolinic synthetic corticosteroid, was studied in 12 healthy adult subjects with a positive family history of diabetes mellitus. Three oral glucose tests (oGTT) were performed at 9.00 a.m., after a 12 h fast, following randomized administration of Placebo (PL), or Defl...
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/BF00542555
更新日期:1982-01-01 00:00:00
abstract:OBJECTIVE:Theophylline is metabolized to 1,3-dimethyluric acid (1,3-DMU), 3-methylxanthine, and 1-methylxanthine by CYP1A2 and partly by CYP2E1. Because 1,3-DMU is the major metabolite of theophylline, the 1,3-DMU/theophylline ratio is viewed as a good indicator of theophylline metabolic clearance. Here, we investigate...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-006-0165-4
更新日期:2006-08-01 00:00:00
abstract::The pharmacokinetics of metoclopramide has been studied after acute IV administration to 12 patients with hepatic cirrhosis (6 with and 6 without ascites) and 6 control subjects. The elimination half-life was significantly longer in patients (11.4 h and 9.9 h in those with and without ascites, respectively, vs 6.4 h i...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00265857
更新日期:1991-01-01 00:00:00
abstract::Jejunal perfusion was performed in 12 healthy volunteers to evaluate the dose dependent effects of loperamide on intestinal absorption, stimulated secretion and transit. In 6 volunteers intestinal perfusion of the jejunal segment with isotonic NaCl solution was followed by addition of loperamide in increasing doses (2...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00315436
更新日期:1991-01-01 00:00:00
abstract::Propranolol (P) and all of its major known metabolites were found in maternal plasma, cord plasma and neonatal plasma in 10 women at term, irrespective of the P doses administered and the time elapsed (up to 15 h) between administration of the last P dose and delivery. The ratios of cord plasma to simultaneous materna...
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/BF00607078
更新日期:1983-01-01 00:00:00
abstract::Plasma concentrations of nitrazepam were measured by gas-liquid chromatography in: young healthy volunteers, in geriatric and psychiatric patients and in epileptic children. The disposition of nitrazepam was described in terms of a two-compartment open model. After a single oral dose of nitrazepam 5 mg the most promin...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00563100
更新日期:1979-04-17 00:00:00
abstract:INTRODUCTION:Epidural hydromorphone could be useful in obstetric analgesia as there is a need for a more water-soluble opioid than sufentanil or fentanyl with prolonged analgesic effect. To our knowledge, the pharmacokinetics of epidural hydromorphone has not been evaluated in parturients. MATERIALS AND METHODS:In thi...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-020-02880-6
更新日期:2020-07-01 00:00:00
abstract:PURPOSE:Treatment failures following vancomycin therapy in patients with methicillin-resistant Staphylococcus aureus infections have led to the utilization of higher doses of this antibiotic to achieve the trough concentrations of 10-20 μg/mL recommended by the Infectious Diseases Society of America clinical practice g...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1007/s00228-012-1259-9
更新日期:2012-09-01 00:00:00
abstract:BACKGROUND:Xanthine oxidase (XO) is one of the two interconvertible forms of xanthine oxidoreductase and well-studied for its role in purine catabolism and that of other purine analogues, drugs especially. Our study investigated the incidence of polymorphism in phenotypes along with the influence of gender and age on e...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-015-1852-9
更新日期:2015-06-01 00:00:00
abstract::To assess the duration of the antihypertensive effect of the dihydropiridine calcium antagonist felodipine in conventional (C-F) and slow-release (ER-F) formulations, 12 patients with essential hypertension underwent ambulatory blood pressure monitoring (ABPM) at the end of a 2-week treatment period with C-F 5 mg b.d....
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/BF00562543
更新日期:1989-01-01 00:00:00
abstract::For model identification and parameter estimation in the framework of linear pharmacokinetics it is most often assumed that the disposition function is a finite sum of exponential functions with time constants lambda i and associated coefficients Ci. Least-square fitting procedures are used to estimate the coefficient...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00315312
更新日期:1993-01-01 00:00:00
abstract::Plasma levels of canrenone and 'total metabolites' after base hydrolysis were compared in young and elderly subjects following single and multiple doses of spironolactone. After the initial dose on Day 1, plasma levels of canrenone and 'total metabolites' were higher in the young than in the elderly group, and signifi...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00549591
更新日期:1984-01-01 00:00:00
abstract:OBJECTIVE:To investigate (1) the pharmacokinetic and pharmacodynamic profiles of desmopressin in men from an age group with a high incidence of nocturia; and (2) circadian variation in the pharmacokinetic parameters. METHODS:The study had an open, randomised, four-way cross-over design. Desmopressin was administered o...
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/s00228-004-0781-9
更新日期:2004-08-01 00:00:00
abstract::A four-period, two-panel, single-rising-dose study (0.1-100 mg) was conducted in healthy males to investigate the pharmacodynamics, tolerability and pharmacokinetics of MK-0434, a steroid 5 alpha-reductase inhibitor. MK-0434 was associated with a significant reduction in dihydrotestosterone, which was maximal at 24 h ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00199874
更新日期:1994-01-01 00:00:00
abstract::The pharmacokinetics of i.v. chloramphenicol succinate and oral chloramphenicol palmitate were studied in Ethiopian children with different nutritional states. In children with kwashiorkor the plasma clearance of chloramphenicol was significantly lower than in children of normal weight (4.16 ml/min/kg versus 7.53 ml/m...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00607094
更新日期:1983-01-01 00:00:00
abstract::Thirty-eight severely hypertensive patients were treated with oral clonidine. Each patient received a "loading" dose of 0.2 mg clonidine, followed by 0.1 mg hourly until the blood pressure was substantially reduced, or until a total dose of 0.8 mg has been administered. Thirty-five (82.1%) patients responded favourabl...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00606664
更新日期:1986-01-01 00:00:00
abstract::In a double-blind, randomized study, the long-term effects of timolol and placebo on FEV1, PEFR, FVC, VC, respiratory rate and heart rate were compared in 32 patients surviving acute myocardial infarction, 17 on timolol and 15 on placebo. The patients were assessed before and after 1, 3 and 6 months of medication, and...
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/BF00635703
更新日期:1985-01-01 00:00:00
abstract::In healthy normal subjects following the administration of labetalol the pharmacological effects were measured and compared with the plasma concentrations achieved. The inhibition of exercise induced tachycardia and inhibition of exercise induced increases in systolic pressure were significantly related to the adminis...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00562897
更新日期:1977-01-03 00:00:00
abstract::The blood level versus time curve for unchanged cimetidine after a 200 mg oral dose has been determined in 20 apparently healthy subjects, ranging from 22 to 84 years of age. A significant relationship between the area under the curve (AUC) and age was found (r = 0.81; P less than 0.001). The peak concentrations of ci...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00618514
更新日期:1979-05-21 00:00:00
abstract::A placebo-controlled, single blind, crossover study was done to evaluate the inotropic effects of single oral doses of mexiletine and disopyramide assessed by the measurement of Systolic Time Intervals (STI). Each of 8 healthy volunteers received five treatments in random order: 200 and 400 mg mexiletine, 100 and 200 ...
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/BF00541525
更新日期:1986-01-01 00:00:00
abstract::The pharmacokinetics of mexiletine, a Class I antiarrhythmic drug, was investigated in 6 healthy volunteers after single oral doses and 15 min intravenous infusions of 3 mg/kg. Cimetidine and ranitidine are commonly used H2-receptor antagonists, which interact adversely with many drugs, e.g. inhibition of the metaboli...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00558298
更新日期:1989-01-01 00:00:00
abstract:OBJECTIVE:To assess the effect of ciprofloxacin on the pharmacokinetics of ropivacaine. METHODS. In a double-blind, randomised, cross-over study, nine healthy volunteers were treated for 2.5 days with 500 mg oral ciprofloxacin or placebo twice daily. On day 3, they received a single dose of 0.6 mg/kg ropivacaine intrav...
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/s00228-002-0540-8
更新日期:2003-02-01 00:00:00
abstract:PURPOSE:The study aimed to describe the dispensing of benzodiazepines and benzodiazepine-related drugs (z-hypnotics) to pregnant women and to study the characteristics of these women and the extent of co-medication. METHODS:A population-based cohort study was conducted based on the linkage of nationwide registries: th...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-014-1744-4
更新日期:2014-11-01 00:00:00
abstract:PURPOSE:Serotonin receptor 1B (HTR1B) is involved in the regulation of the serotonin system, playing different roles in specific areas of the brain. We review the characteristics of the gene coding for HTR1B, its product and the functional role of HTR1B in the neural networks involved in motivation and memory; the cent...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1007/s00228-009-0724-6
更新日期:2010-01-01 00:00:00
abstract:PURPOSE:The purpose of this study was to systematically review evidence regarding the association between regimen complexity and adherence. METHODS:Articles were searched in MEDLINE, LILACS, Cochrane, CINAHL, PsycINFO and references of included studies. Search terms included medication regimen complexity, medication a...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1007/s00228-017-2315-2
更新日期:2017-11-01 00:00:00
abstract:OBJECTIVE:UDP-glucuronosyltransferases (UGTs) UGT1A9 and UGT2B7 are involved in the metabolism of antimalarial dihydroartemisinin and antiretroviral zidovudine. Our aim was to analyze the prevalence of UGT1A9 (chromosome 2) and UGT2B7 (chromosome 4) nonsynonymous single nucleotide polymorphisms (SNPs) in West African (...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-006-0206-z
更新日期:2007-01-01 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