Examples of using Data from studies in English and their translations into Romanian
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There are no data from studies in breast-feeding women.
To support the use of tenofovir alafenamide,the company provided data from studies showing that.
There are no data from studies in breast-feeding women.
Although ImmunoGam itself was not tested in experimental models,the applicant presented adequate data from studies using similar medicines.
Efficacy data from Studies 1001 and 1005 are provided in Table 6.
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The company that makes Firdapse will provide further data from studies on cancer in experimental models.
Data from studies with other interferon beta compounds did not show teratogenic potential.
Safety data mainly refer to 48-week data from studies TORO 1 and TORO 2 combined(see section 5.1).
Data from studies with human liver microsomes indicated that the carboxylic acid metabolite of clopidogrel could inhibit the activity of Cytochrome P450 2C9.
Durability of HBeAg-seroconversion Durability of HBeAg-seroconversion was assessed from pooled data from studies NV-02B-007 and NV-02B-015.
The company provided data from studies to determine that it is bioequivalent to the reference medicine, Xeloda.
Frequent visitors are students, graduates andresearchers who find here photographs, documents and summarized data from studies in the field and a rich literature.
Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.
Because Leucofeligen FeLV/RCP is made up of two vaccines that have been available in the European Union(EU) since the 1980s(Feligen RCP and Leucogen),the company used data from studies carried out with these vaccines to support the use of Leucofeligen FeLV/RCP.
A new analysis of data from studies of cancer survival rate of children after ischemic heart disease shows a decrease.
Data from studies in rats and dogs indicate that male and female fertility may be irreversibly compromised by treatment with Odomzo(see section 5.3).
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005, and 1007, age has no effect on crizotinib pharmacokinetics(see sections 4.2 and 5.1).
Data from studies that have been conducted and published previously or coming from peer review shall clearly refer to the same additive as the one subject to the application for authorisation.
In addition, the population pharmacokinetic analysis using data from Studies 1001, 1005 and 1007 indicated CLcr did not have a clinically meaningful effect on the pharmacokinetics of crizotinib.
The efficacy data from studies AVF0780g and AVF2192g investigating Avastin in combination with 5-FU/ FA-chemotherapy are summarised in Table 4.
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, there was no clinically meaningful effect of body weight or gender on crizotinib pharmacokinetics.
Non-clinical safety data from studies performed with pasireotide administered via the subcutaneous route reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Based on the population pharmacokinetic analysis of data from Studies 1001, 1005 and 1007, the predicted steady-state AUC(95% CI) was 23%-37% higher in Asian patients(N=523) than in non- Asian patients(N=691).
There are no adequate and well-controlled data from studies in pregnant women, however transient B-cell depletion and lymphocytopenia have been reported in some infants born to mothers exposed to rituximab during pregnancy.
To support the use of tenofovir alafenamide,the company provided data from studies showing that combination medicines containing tenofovir alafenamide are as effective in reducing the amount of HIV-1 in the blood as those containing tenofovir disoproxil.
However, due to their long history of safe use, data from studies already published may be used, under provisions provided by this Regulation, to show that the additive remains safe under the approved conditions for the target species, consumers, users and the environment.
And 144-week efficacy data from study GS-01-934 in which emtricitabine, tenofovir disoproxil fumarate and efavirenz were administered to antiretroviral-naïve patients with HIV-1 infection.
A concentration-QTc response analysis based on the data from Study A demonstrated that at average steady-state concentrations the upper bound of the 2-sided 90% CI for QTc increase from baseline was 16 msec at Zykadia 750 mg.
Data from study ALLY-3(AI444218) support a 12-week treatment duration of Daklinza+ sofosbuvir for treatment-naïve and-experienced patients with genotype 3 infection without cirrhosis.
Administration of fosamprenavir 700 mg twice daily with ritonavir 100 mg twice daily results in plasma amprenavir concentrations(data from study APV30003 in antiretroviral experienced patients) which results in protein adjusted median ratios of Cmin/ IC50 and Cmin/ IC95 of 21.7(range 1.19-240) and 3.21(range 0.26-30.0), respectively.