Abstract：
INTRODUCTION:Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each 'Member State concerned' to arrive at 'one single decision' regarding the application for authorisation to conduct a trial. PROPOSALS:The Regulation should be implemented in such a way as to avoid a separation between scientific assessment and ethical assessment; guarantee the absence of conflicts of interest in the institutions responsible for decision-making; promote efficiency on the part of ethics committees. In particular, (i) it is not appropriate to assess Parts I and II of the application for approval to conduct a trial separately (scientific soundness is the principal requisite for ethical soundness); (ii) conflicts of interest should be avoided, especially as regards links with the national authority responsible for drugs regulation; (iii) decision-making in each state should be the responsibility of a single coordinating ethics committee divided into sections specialising in different therapeutic fields; (iv) local committees affiliated to institutions where trial participants are recruited should be able to interact with the coordinating committee, provide consultation services-including on issues of clinical ethics-and promote training in the field of biomedical ethics.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Petrini C,Garattini Sdoi
10.1007/s00228-016-2009-1subject
Has Abstractpub_date
2016-04-01 00:00:00pages
503-5issue
4eissn
0031-6970issn
1432-1041pii
10.1007/s00228-016-2009-1journal_volume
72pub_type
杂志文章abstract：PURPOSE:To determine whether two of the major operational stressors associated with military missions in Afghanistan: dry heat and long durations of soldier patrol (SP), alter the pharmacokinetics of ibuprofen. METHODS:Thirteen healthy and physically fit participants (19-32 years) were randomized to a four-arm crossov...
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/s00228-012-1307-5
更新日期：2013-01-01 00:00:00
abstract：AIMS:Thiazolidinediones administration is assumed to be related with an improvement of endothelial dysfunction (ED); nevertheless, previous studies have been inconsistent. For this reason, the present meta-analysis was directed to estimate if thiazolidinediones were related to endothelial dysfunction improvement by usi...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,meta分析,评审
doi：10.1007/s00228-015-1999-4
更新日期：2016-04-01 00:00:00
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：INTRODUCTION:Reimbursement databases are potentially invaluable tools to develop and conduct pharmacoepidemiological studies on drug use. However, two types of factors that may influence the performance of a database can be distinguished: firstly, factors related to the constitution of the database, and secondly, facto...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-010-0819-0
更新日期：2010-07-01 00:00:00
abstract：PURPOSE:Methylenedioxymethamphetamine (MDMA, ecstasy) is used recreationally and frequently leads to sympathomimetic toxicity. MDMA produces cardiovascular and subjective stimulant effects that were shown to partially depend on the norepinephrine transporter (NET)-mediated release of norepinephrine and stimulation of α...
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/s00228-017-2392-2
更新日期：2018-03-01 00:00:00
abstract：:Twenty-nine cases of self-poisoning with antidepressants (amitriptyline, imipramine, clomipramine, maprotiline, doxepine, nortriptyline, opipramol) were examined by frequent observation of CNS effects, heart rate, blood pressure and standard ECG, 24h-ECG-monitoring, measurement of systolic time intervals, EEG recordin...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00637499
更新日期：1982-01-01 00:00:00
abstract：:This is the first report of the use of DHM 32-550 a dehydrogenated peptide ergot alkaloid with both alpha and beta adrenoceptor blocking activity, in patients with angina-like chest pain. Five patients were studied to assess a dose/response relationship. No deleterious effects on blood pressure occurred at either rest...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF00544034
更新日期：1984-01-01 00:00:00
abstract：PURPOSE:Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for ovarian and metastatic breast cancer. Increased serum creatinine levels have been observed in patients taking olaparib, but the underlying mechanism is unknown. This study aimed to investigate if patients receiving olaparib have increased...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-020-03070-0
更新日期：2021-02-01 00:00:00
abstract：PURPOSE:Older people with several chronic conditions require multiple drugs from different classes to be adequately treated. This study aims to: (i) measure medication adherence across multiple conditions and therapeutic drug groups in older community-dwelling patients, and (ii) examine the effect of multimorbidity on ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,多中心研究
doi：10.1007/s00228-017-2388-y
更新日期：2018-03-01 00:00:00
abstract：PURPOSE:Our aim was to observe the impact of CYP3A4*1G genetic polymorphism on lipid-lowering efficacy of statins. METHODS:We studied 217 unrelated hyperlipidemic patients who prospectively received atorvastatin and 199 patients who received simvastatin as a single-agent therapy (20 mg day(-1) p.o.) for 4 weeks. Genot...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-008-0502-x
更新日期：2008-09-01 00:00:00
abstract：PURPOSE:The aim of the study was to develop a European list of potentially inappropriate medications (PIM) for older people, which can be used for the analysis and comparison of prescribing patterns across European countries and for clinical practice. METHODS:A preliminary PIM list was developed, based on the German P...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,多中心研究
doi：10.1007/s00228-015-1860-9
更新日期：2015-07-01 00:00:00
abstract：:The benzamide-derivative moclobemide (Ro 11-1163) is a new short-acting, reversible MAO-inhibitor, preferentially affecting Type A MAO, which is, being developed as an antidepressant agent. The effect of moclobemide on heart rate, blood pressure, electrocardiographic and systolic time intervals was assessed in eight h...
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/BF00543787
更新日期：1983-01-01 00:00:00
abstract：OBJECTIVE:To evaluate the effect of the CYP2D6 genotype on the pharmacokinetics of tropisetron in healthy Korean subjects. METHODS:A single 5-mg capsule of tropisetron was administered orally to 13 healthy subjects. Plasma concentrations were determined by validated HPLC procedures and data were analyzed by using nonc...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-003-0595-1
更新日期：2003-06-01 00:00:00
abstract：INTRODUCTION:This study compared the characteristics of new human drugs approved by the Food and Drug Administration (FDA), the European Medicine Agency (EMA), and Swissmedic (SMC) in the period 2007 to 2016. METHODS:The list of new drugs and therapeutic biologics approved by the FDA, the EMA, and SMC in the period 20...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-018-2431-7
更新日期：2018-06-01 00:00:00
abstract：:A single dose of 60 mg trimetazidine (the normal daily dose) improved exercise capacity in angina pectoris, as reflected by an increase in the duration of exercise, total work performed, and improvement in ECG signs of ischaemia. All these effects occurred without any detectable chronotropic or vasomotor effect. The i...
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/BF00544569
更新日期：1987-01-01 00:00:00
abstract：:All forensic autopsy cases in southern Sweden in 1986-89 in which antidepressant drugs were found in the blood were assessed and the findings related to the sales of antidepressants as expressed as defined daily doses per 1,000 inhabitants per day. There was a total of 272 antidepressant-positive cases, which were div...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00194393
更新日期：1994-01-01 00:00:00
abstract：OBJECTIVE:To study the influence of CYP3A4 inhibition by ketoconazole on the disposition of venlafaxine in individuals with different CYP2D6 pheno- and genotypes. METHODS:In an open two-phase study, 21 healthy volunteers with known CYP2D6 pheno- and genotype [14 extensive metabolisers (EMs), 7 poor metabolisers (PMs)]...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-003-0627-x
更新日期：2003-09-01 00:00:00
abstract：:Enprofylline 1 mg/kg, a new potent antiasthmatic xanthine derivative, which is mainly eliminated by renal excretion, was given intravenously to 6 normal subjects with and without oral pretreatment with 1 g probenecid. The latter caused a drop in the average total body clearance of enprofylline from 21 to 9.8 l/h, and ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00614308
更新日期：1986-01-01 00:00:00
abstract：:The effects in vitro and in vivo of triiodothyronine on certain functions of human lymphocytes and polymorphonuclear granulocytes have been investigated. Triiodothyronine was able to enhance the phagocytic capacity and chemiluminescent activity of polymorphonuclear granulocytes. PHA-P-induced 3H-thymidine incorporatio...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00561672
更新日期：1980-01-01 00:00:00
abstract：:Changes in phenytoin concentrations caused by switching valproate formulations with different absorption rates were retrospectively investigated in eleven epileptic patients receiving treatment with both drugs. Total plasma phenytoin concentrations were measured before and after a standard tablet of valproate was repl...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF00202174
更新日期：1995-01-01 00:00:00
abstract：PURPOSE:Pre-clinical experiments have shown that almorexant, a dual orexin receptor antagonist, is able to inhibit cytochrome P450 3A4 (CYP3A4). Therefore, a study was conducted to investigate the effects of multiple-dose almorexant on the pharmacokinetics of midazolam and simvastatin, two CYP3A4 model substrates. MET...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-012-1403-6
更新日期：2013-03-01 00:00:00
abstract：OBJECTIVE:To develop quality prescribing indicators for general practitioners (GPs) who are non-monitored and not included in pay-for-performance programs, and to determine compliance with incentivized and non-incentivized indicators. STUDY DESIGN:Descriptive cross sectional study. SETTING:Aljarafe Primary Health Car...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-013-1542-4
更新日期：2013-10-01 00:00:00
abstract：OBJECTIVE:Withdrawal of a drug from the market for safety reasons is a serious and sometimes complex decision. The scientific evidence supporting drug withdrawals in the past years is critically appraised. METHODS:With data provided by the Spanish Medicines Agency, all drugs withdrawn from the Spanish market for safet...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/s002280100265
更新日期：2001-04-01 00:00:00
abstract：:In Belgium, all dispensed drugs are provided with package inserts. Traditional physician-orientated inserts are gradually being replaced by patient package inserts (PPIs). The present survey is focused on the use of inserts for antihypertensive drugs and their impact on the reported occurrence and attribution of adver...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00316093
更新日期：1990-01-01 00:00:00
abstract：PURPOSE:Pharmacodynamic studies of naloxone require opioid agonism. Steady state condition may be achieved by remifentanil TCI (target controlled infusion). Opioid agonism can be measured by pupillometry. It is not known whether there are arteriovenous concentration differences for naloxone. The aim was thus to further...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-018-2545-y
更新日期：2018-12-01 00:00:00
abstract：OBJECTIVE:To evaluate the impact of the two most common CYP2C9 variant alleles (*2 and *3) on the maintenance dose of warfarin and on the quality of anticoagulation control in Brazilians. METHODS:Patients (n = 103) initiated warfarin therapy with 5 mg/day (or 2.5 mg/day when over 80 years old). The international norma...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-007-0385-2
更新日期：2008-01-01 00:00:00
abstract：:Of 23 patients with non-insulin-dependent diabetes mellitus (NIDDM), whose fasting blood glucose had not reached less than or equal to 6.0 mmol.l-1 after 10 weeks of dietary regulation, 15, who had had a weight reduction of -2.8 kg by dietary control, did achieve a fasting blood glucose less than or equal to 6.0 mmol....
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00314924
更新日期：1992-01-01 00:00:00
abstract：AIM:The investigations reported here aimed to evaluate the incremental benefit for dose finding by concentration-response analysis versus dose-response analysis. METHODS:Trials were simulated using an Emax model for a range of scenarios of drug properties, trial design options and target response levels. The simulated...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-013-1474-z
更新日期：2013-07-01 00:00:00
abstract：PURPOSE:This study compares the in vivo relative lung bioavailability of Hydrofluoroalkane (HFA) Seretide delivered via unprimed and unwashed Aerochamber Plus (AP) or Volumatic (VM) spacers, a integrated breath-actuated vortex Synchro-Breathe (SB) device and an Evohaler pMDI (EH) device using adrenal suppression and ea...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-010-0989-9
更新日期：2011-04-01 00:00:00
abstract：PURPOSE:This exploratory study was aimed at elucidating the pharmacogenetics of regulatory nuclear receptors (PXR, CAR, RXRα and HNF4α) and their implications on docetaxel pharmacokinetics and pharmacodynamics in local Chinese nasopharyngeal cancer patients. METHODS:A total of 59 single nucleotide polymorphisms (SNPs)...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-013-1596-3
更新日期：2014-02-01 00:00:00
