Abstract：
BACKGROUND:Pharmacovigilance, defined by the World Health Organisation as 'the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem' plays a key role in ensuring that patients receive safe drugs. Our knowledge of a drug's adverse reactions can be increased by various means, including spontaneous reporting, intensive monitoring and database studies. New processes, both at a regulatory and a scientific level, are being developed with the aim of strengthening pharmacovigilance. On a regulatory level, these include conditional approval and risk management plans; on a scientific level, transparency and increased patient involvement are two important elements. OBJECTIVE:To review and discuss various aspects of pharmacovigilance, including new methodological developments.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Härmark L,van Grootheest ACdoi
10.1007/s00228-008-0475-9subject
Has Abstractpub_date
2008-08-01 00:00:00pages
743-52issue
8eissn
0031-6970issn
1432-1041journal_volume
64pub_type
杂志文章,评审abstract：OBJECTIVE:To investigate if an intervention aimed at improving the quality of the diagnostic procedures in Spanish general practice could lower antibiotic prescribing in patients with respiratory tract infections (RTIs). METHODS:GPs in the intervention group (n=17) registered all patients with RTIs during a 3-week per...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-006-0187-y
更新日期：2006-11-01 00:00:00
abstract：:The inhibitory action of azelastine hydrochloride (Azeptin) on the respiratory burst in peripheral polymorphonuclear leukocytes (PMN) and pulmonary alveolar macrophages (PAM) has been studied. Azeptin in vitro suppressed chemiluminescence and superoxide (O2-) generation by human PMN in a dose- and time-dependent manne...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00194963
更新日期：1994-01-01 00:00:00
abstract：:The cleansing effects on pus and debris of streptokinase-streptodornase and of stabilized crystalline trypsin were compared in 40 patients (12 males, 28 females) with necrotic varicose or arteriosclerotic leg ulcers. Both preparations produced significant partial or total cleansing of the ulcers of necrotic material, ...
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/BF00542211
更新日期：1983-01-01 00:00:00
abstract：CONTEXT:Adverse drug reactions (ADRs) are responsible for 5 % of hospital admissions, but hospital re-admission induced by ADRs remains poorly documented. OBJECTIVE:The aim of this study was to estimate the rate of hospital re-admission and the factors associated with re-admission in the patients over the age of 65 ye...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-016-2022-4
更新日期：2016-05-01 00:00:00
abstract：:To assess the partial agonist activity of cicloprolol in man, four studies were carried out in normal male volunteers. I and II. Open dose escalating studies of the effects of oral doses of the drug on exercise tachycardia and sleeping heart rate. III and IV. Double-blind randomized studies of the effects of placebo, ...
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/BF00615219
更新日期：1988-01-01 00:00:00
abstract：:The binding of ibuprofen to human serum albumin, normal plasma and plasma obtained from rheumatoid arthritic patients was studied using the method of ultracentrifugation. It was found that ibuprofen is more strongly bound to normal plasma than to human serum albumin although this result is probably explained by fatty ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00542526
更新日期：1983-01-01 00:00:00
abstract：:The effect of the aminoglycosides amikacin, gentamicin, netilmicin sisomicin and tobramycin on the proximal tubule of the human kidney was investigated in 78 healthy subjects. Fifteen adults were each given gentamicin, sisomicin or tobramycin 3 mg/kg bodyweight, 10 subjects received netilmicin 3 mg/kg or amikacin 15 m...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00609758
更新日期：1978-05-17 00:00:00
abstract：INTRODUCTION:The aim of therapeutic regimens using proton pump inhibitors (PPIs) in patients with acid-related diseases is to potently inhibit acid secretion for the full 24 h. However, optimum treatment is still unclear because the pharmacodynamics of PPIs differ among CYP2C19 genotypes and most of the previous studie...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-014-1713-y
更新日期：2014-09-01 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：:Repeated doses of a 1,5 benzodiazepine, clobazam, were administered to a group of consenting volunteers. Performance on a psychomotor performance task was not impaired by repeated doses of the drug. Subjective assessments of anxiety were reduced commensurate with an increase in the level of cortical integration, measu...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00644961
更新日期：1979-08-01 00:00:00
abstract：:The effects of a 10 day administration of clomipramine (25-50 mg t.i.d.), alprazolam (0.25-0.75 mg t.i.d.) and placebo were assessed in normal volunteers in a double-blind cross-over study. A battery of physiological, psychomotor and cognitive tests was administered both before and 3 h after drug on days 1, 5 and 10. ...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF00265843
更新日期：1991-01-01 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：:Verapamil, 0.1 mg/kg body wt, was injected i.v. over 2 minutes in 8 subjectively healthy middle-aged men, followed by a continuous infusion of 0.007 mg/kg body wt per minute. Prior to the injection several of the subjects had raised pulmonary or systemic arterial pressures. At rest, the central pressures increased sli...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00562656
更新日期：1975-06-13 00:00:00
abstract：:In this paper an alternative approach to nonlinear pharmacokinetics modelling has been developed from first principles. This "Unsteady Model" is able to describe the situation whereby one or more independent drugs and their metabolites compete for free attachment sites in liver, tissue, red blood cells etc. The Unstea...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00615410
更新日期：1981-01-01 00:00:00
abstract：PURPOSE:Alcohol dependence is a public health problem worldwide, commonly associated with withdrawal symptoms for which diazepam is a frequently used drug. We studied the effect of CYP2C19 gene polymorphisms on diazepam loading dose requirement and time to reversal of acute alcohol withdrawal symptoms. We also studied ...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-016-2061-x
更新日期：2016-07-01 00:00:00
abstract：:To assess the type and degree of innovation of the cardiovascular drugs centrally approved in the European Union between 1995 and 2002. Sources of information were the European Public Assessment Reports and the Summaries of Product Characteristics published by the European Medicines Evaluation Agency. The Agency appro...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-003-0634-y
更新日期：2003-11-01 00:00:00
abstract：:The gastric inhibitory effects of CM57755, a new histamine H2 receptor antagonist, have been compared in ten healthy male volunteers with the actions of an equal dose of cimetidine and with placebo. The inhibitory effect of CM57755 was virtually identical with, and not significantly different from the effects of cimet...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF00614192
更新日期：1986-01-01 00:00:00
abstract：PURPOSE:To investigate the impact of valproic acid (VPA) and genetic polymorphism of the major metabolizing enzyme (UGT1A4, UGT2B7) of lamotrigine (LTG) and VPA on LTG concentration in Chinese epileptic children. METHODS:Three single nucleotide polymorphisms (UGT1A4*3, UGT2B7 -161C > T and UGT2B7*2) were analyzed by p...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-015-1925-9
更新日期：2015-11-01 00:00:00
abstract：:The pharmacokinetics of cefixime following a single oral dose of 200 mg have been investigated in 6 normal subjects and in 22 patients with various degrees of renal insufficiency. Serum and urine samples were collected between 0 and 72 h and were subjected to two methods of analysis: bioassay and HPLC. There was a lin...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00314988
更新日期：1991-01-01 00:00:00
abstract：:In this paper pharmaceutical and biopharmaceutical aspects on the development of long-acting nitrate delivery systems are reviewed. Basic considerations and requirements are also discussed. Recent product development activities are presented, with an emphasis on nitroglycerin in transdermal form and oral isosorbide-5-...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/BF01417560
更新日期：1990-01-01 00:00:00
abstract：OBJECTIVE:Although the treatment of schizophrenia with many second generation antipsychotics is known to be associated with metabolic changes, such as hyperglycemia or hypercholesterolemia, the underlying mechanisms of these adverse reactions remain unclear. In light of the recent focus on the involvement of semicarbaz...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-007-0272-x
更新日期：2007-05-01 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：PURPOSE:To investigate associations between antidepressant use patterns and risk of fatal and non-fatal suicidal behaviours in older adults who initiated antidepressant therapy. METHOD:A national population-based cohort study conducted among Swedish residents aged ≥ 75 years who initiated antidepressant treatment. Pat...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-017-2360-x
更新日期：2018-02-01 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：:Naftopidil exerts its antihypertensive action via alpha 1-adrenoceptor blockage and Ca2+ antagonism in vascular smooth muscle. Since the chemically similar 1-(1-naphthyl) piperazine is known to be a 5-hydroxytryptamine2 receptor antagonist, the 5-hydroxytryptamine (5-HT) antagonistic properties of naftopidil were test...
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/BF00192561
更新日期：1994-01-01 00:00:00
abstract：:Levosimendan is a new calcium-sensitiser intended for the treatment of congestive heart failure. The results of preclinical studies indicate it has positive inotropic and vasodilator effects. In the open study reported here up to 5 mg levosimendan and vehicle were administered to 8 healthy male volunteers at one- to 2...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF02570507
更新日期：1994-01-01 00:00:00
abstract：:1. The effect of pre-dosing with 15 mg domperidone, a relatively selective dopamine 2-receptor antagonist, on the ocular hypotensive action of a single oral dose of 25 micrograms pergolide, a dopamine 2-receptor agonist, was studied in 9 normal human volunteers, using a non-invasive method. 2. Compared with domperidon...
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/BF02336684
更新日期：1990-01-01 00:00:00
abstract：:A possible pharmacokinetic interaction between theophylline and repirinast has been investigated in asthmatic patients. The kinetics of theophylline was studied in seven adult in-patients given theophylline 400-800 mg b.d. alone and after three weeks of co-administration of repirinast. There was no effect on the kinet...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00679789
更新日期：1989-01-01 00:00:00
abstract：OBJECTIVE:To investigate the effects of rifampicin on the pharmacokinetics of itraconazole in humans. METHODS:Our study was conducted with six healthy normal volunteers and three AIDS patients. All subjects received a 200 mg single dose of oral itraconazole on day 1 and day 15 and 600 mg of oral rifampicin once daily ...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s002280050437
更新日期：1998-04-01 00:00:00
abstract：OBJECTIVE:To determine the possible interaction between the antihypertensive agent cicletanine and the hypoglycaemic drug tolbutamide. METHODS:Time-courses of glycaemia and serum immunoreactive insulin (IRI) were followed in 10 healthy subjects after two tolbutamide infusions in each volunteer; initially alone and 9 d...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280050127
更新日期：1996-01-01 00:00:00
