Examples of using Clinical data in English and their translations into Croatian
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No adjustment of the starting dose is needed for patients with mild hepatic impairment(Child Pugh A) based on clinical data.
Once daily administration of lopinavir/ritonavir is not recommended for pregnant women due to the lack of pharmacokinetic and clinical data.
The aim of this study was to analyze clinical data of patients diagnosed with brain tumors and epilepsy.
Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
STEMI, there are limited clinical data available on the use of fondaparinux 2.5mg once daily in patients with creatinine clearance between 20 and 30 ml/min.
The clinical data together with non-clinical data generated from non-clinical testing methods
This section shall provide a brief integrated summary that critically analyses the non-clinical and clinical data in relation to the potential risks
However, for iteration of devices already on the market and for which clinical data are available and for which the data from the post-market surveillance are not indicating any safety concerns, demonstration of equivalence
scientifically challenge the clinical data contained within the clinical evaluation,
If there is some special aspect of the pre-clinical data or clinical data that requires a detailed expert explanation
Clinical data in children less than 6 years of age who received two doses of another Pandemic influenza vaccine(H5N1 manufactured in Dresden, Germany) indicate an increase in frequency of fever(axillary≥38°C)
Be able to discuss the clinical data contained within the manufacturer's clinical evaluation with the manufacturer
Based on 12-month clinical data, the most commonly reported adverse reaction was conjunctival hyperaemia(mostly trace to mild
scientifically challenge the clinical data contained within the performance evaluation,
However, additional clinical data showed that in patients receiving 200 mg twice daily,
A population pharmacokinetic analysis conducted on all clinical data available suggests that the disposition of dinutuximab is not altered by age,
By extrapolation from clinical data on combination therapy with standard interferon in paediatric patients(negative predictive value 96% for interferon alfa-2b/ribavirin),
scientifically challenge the clinical data contained within the clinical evaluation,