Примери за използване на Studies were performed на Английски и техните преводи на Български
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All studies were performed in cancer patients.
Some of the data are new studies conducted according to the recommended OECD guidelines and in compliance with GLP, those studies were performed following questions raised during the Decentralised Procedure.
Therefore the studies were performed as open-label studies. .
No studies were performed to evaluate whether veralipride has an effect on QT.
The majority of controlled clinical studies were performed in patients with advanced breast cancer.
No studies were performed on the mutagenic potential of Nuwiq.
Reproduction toxicity Teratology studies were performed in two species, both via subcutaneous administration.
No studies were performed with albumin bound nanoparticules.
In addition, it was not known whether the studies were performed with batches of vaccines approaching the end of their shelf life.
No studies were performed on the mutagenic potential of KOGENATE Bayer, since no mutagenic potential could be detected in vitro or in vivo for the predecessor product of KOGENATE Bayer.
Effect of renal impairment No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of Zoely.
No studies were performed in patients with end-stage renal impairment requiring dialysis.
However, these studies are of limited relevance because studies were performed with single daily dosing resulting in less than one tenth of daily doripenem exposure duration in animals.
These studies were performed with ritonavir boosted elvitegravir.
The Committee also noted that the studies were performed by the applicant before the publication of recent updated guidance1 for products of this type.
New studies were performed in 2011 and 2012 regarding the genotoxicity of the parent compound(TCC), its main circulating metabolite SL18.0740 and the aglycone metabolite SL59.0955.
All three field studies were performed in animal shelter situations within a limited geographical area.
No studies were performed to assess the effects of NexoBrid on fertility.
However because the studies were performed on animals, it is not clear whether the same applies to humans.
Both studies were performed in North American and/or Asian patients.
Four randomized controlled studies were performed in dialysis patients treated with darbepoetin alfa or epoetinat the time of enrollment.
Both studies were performed with Chironomus riparius exposed via spiked sediment.
The first pharmacokinetic studies were performed by the applicant/MAH in 2009-2010 and submitted in the first DCP starting in January 2011.
All studies were performed with Equilis Prequenza Te(comment: double; mentioned in next paragraph).
No studies were performed to evaluate the effect of renal disease on the pharmacokinetics of IOA.
These studies were performed under laboratory as well as under typical European farming conditions.
No studies were performed on animals to evaluate the effects on reproduction with the CE/BZA combination.
Most of the studies were performed with Equilis Prequenza Te, a vaccine that protects against equine influenza as well as against tetanus.
No genotoxicity studies were performed as the active substance is unlikely to interact directly with DNA or other chromosomal material.
Additional studies were performed with Vectibix as a single agent in patients with other solid tumours and in combination with chemotherapy with and without bevacizumab in patients with mCRC or in combination with chemotherapy in patients with non-small cell lung cancer.