The aim of the study was to find out when and where it is the best toperform bronchoscopic needle aspiration (BNA) for confirmation of mediastinal lymph node metastases in patients with lung cancer.

the term 'competent authority' means an authority of a party with the power to conduct inspection or study audits on facilities in its territory to confirm their compliance with the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party;

Each party shall, in accordance with its applicable laws, regulations and administrative provisions and through appropriate means such as study audits, inspections or monitoring, ensure that the confirmed facilities fulfil the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party specified in the relevant Sectoral Annex.

The MAH was also requested to substantiate the bridging of pharmacokinetic studies and dose-confirmation studies data to prove efficacy.

However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “ Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”.

Lesions responding during the first 12 weeks on study, initial blinded phase, confirmed over at least four study weeks (confirmation of response may have occurred after 12 weeks for some lesions in Study 1).

actively assisting in the identification of centres of bluetongue infection in the Member States by studying viral isolates sent to it for confirmation of diagnosis, classification and epizootiological studies;

6/ 21 No dose confirmation studies appear to have been presented in this study and therefore it was important that the references provided should present robust evidence for the field efficacy of the product.

No dose confirmation studies appear to have been presented the above mentioned study, therefore it is important that the references provided should present robust evidence for the field efficacy of the product.

In study C04-001 (TRIUMPH) PNH patients with at least 4 transfusions in the prior 12 months, flow cytometric confirmation of at least 10% PNH cells and platelet counts of at least 100,000/microliter were randomized to either Soliris (n = 43) or placebo (n = 44).

When tests are evaluated and interpreted, limitations in the extent to which the results of animal and in vitro studies can be extrapolated directly to man must be considered and therefore, evidence of adverse effects in humans, where available, may be used for confirmation of testing results.

the term "competent authority" means an authority of a party with the power to conduct inspection or study audits on facilities in its territory to confirm their compliance with the criteria for confirmation set out in the applicable laws, regulations and administrative provisions of that party;

If the competent authority which received the original notification fails to comply with the suggestions of other authorities regarding further information, confirmation tests or amendments in the study programmes provided for in Annex VIII or the assessment of the risks, it shall give its reasons to the other authorities concerned.