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European clinical trial

Flowever, some associated materials might be perceived as toxic. For example, complexes of osmium find frequent use as electron mediators, because of their rich chemistry, stability, and redox activity. Osmium metal and most compounds are considered nontoxic, but the neat tetroxide of osmium is a strong oxidizer and is considered highly toxic in the U.S. and very toxic by the European Union. On the other hand, the aqueous solution, osmic acid, has been injected at 1% concentration in several European clinical trials, starting in the 1970s, for treatment of arthritis and hemophilia. - No toxic effects were observed. Thus, osmium toxicity might be a question not of in vivo chemistry, but of manufacture, where a concentrated form of the oxide might need to be handled. ... [Pg.631]

European clinical trial products do not currently require manufacture to GMP however, a new clinical trial directive is undergoing implementation and will necessitate the manufacture to GMP in licensed premises. [Pg.107]

All formulations for administration to humans must be prepared in compliance with good manufacturing practice (GMP) and the certificates of analysis must be provided. The European Clinical Trials Directive requires that details of the formulations be provided to, and approved by, regulatory authorities and a qualified person at the investigator site(s). In principle, the Directive has been in force throughout the EU since May 2004 though it has been implemented at various times in different member states. The Directive applies to healthy volimteer as weU as patient studies. The requirements for pharmaceutical products for administration to humans are summarised in Box 4.6. [Pg.151]

Baeyens AJ. Impact of the European Clinical Trials Directive on academic clinical research. Med Law 2004 23 103-110. [Pg.533]

There have been five double-blind studies comparing the antidepressant efficacy of different SSRIs versus different TCAs in patients with HDRS scores of 25 or more (122, 123,124, 125 and 126). Three of these studies permitted inclusion of both inpatients and outpatients ( 122, 123 and 124), whereas the other two were solely done in outpatients (125, 126). Three were placebo-controlled (1.23, 125,126). In these three studies, the SSRI (i.e., fluvoxamine, paroxetine, or sertraline) was either superior to both the f CA and placebo or was comparable with the TCA and superior to placebo. In the other two studies, the SSRI was not different from the TCA and there was no placebo control. There have also been four studies and one metaanalysis of European clinical trials which found no difference in antidepressant efficacy between several different SSRIs and several different tertiary amine TCAs in patients hospitalized for major depression ( 127,128, 129,130 and 131). Finally, there have been two relatively small studies showing that fluoxetine and fluvoxamine both had antidepressant efficacy superior to placebo in patients with melancholia ( 132, 133). Another larger study failed to find a difference between paroxetine and amitriptyline in treating such patients ( 134). [Pg.121]

European Clinical Trials Database. EudraCT supporting documentation, http // eudract.emea.eu.int/document.html... [Pg.90]

The European Clinical Trials Directive has now standardized the submissions to regulatory authorities needed for phase I studies within the European Community. The data in support of such submissions are now more or less the same as for an IND in the United States, and there is comparable institutional review board/ethics committee review and oversight on both sides of the North Atlantic. The preclinical manager must keep a close eye on the pace of such studies so that the preclinical testing for phase I in humans, which is usually rate limiting, causes as little delay as possible. [Pg.64]

The European clinical trial directive has the central objective of protecting subjects taking part in medical research. The principles within Declaration of Helsinki (as amended) are now integrated into the legal framework by inclusion in the GCP guidelines (and also the GMP guidelines, see next section). Briefly, these principles are the following ... [Pg.452]

Detailed guidance on the European clinical trial database (EuDRACT database) ENTR/F2/BL D (2003). [Pg.484]

European Commission. Detailed guidance on the European clinical trials database (EuDRACT Database). April 2003, and successor documents CT 5.1 Amendment describing the development of EUDRACT-Lot 1 (May 1, 2004) and CT 5.2 EUDRACT core dataset. [Pg.485]

E. Exchange of Information, Suspension or Infringements, European Clinical Trials EUDRACT Database... [Pg.469]

Cameron, A.M., The European Clinical Trials Directive, Global Outsourcing Review, 4, pp. 50-52 (2002). [Pg.208]

European Commission (2003 b) Detailed guidance on the European clinical trials database (Eu-draCT Database). http //pharmacos.eudra.org/F2/pharmacos/docs/Doc2003/april/cp-guidance-eudract 230403.pdf)... [Pg.171]

The year 2003 saw the launch of the European Clinical Trials (EudraCT) Database (https //eudract.emea.eu.int/eudract/index.do). The database is interfaced with the Eudravigilance Clinical Trial Module (EVCTM), and is used to facilitate communication on clinical trials between authorities in the oversight of clinical trials and investigational medicinal product development, and to provide for enhanced protection of clinical trial participants receiving investigational medicinal products. [Pg.90]


See other pages where European clinical trial is mentioned: [Pg.293]    [Pg.257]    [Pg.502]    [Pg.501]    [Pg.187]    [Pg.187]    [Pg.502]    [Pg.820]    [Pg.449]    [Pg.2454]    [Pg.101]    [Pg.306]   
See also in sourсe #XX -- [ Pg.78 , Pg.134 ]




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