Examples of using Based on cmax in English and their translations into Romanian
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In younger p atients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
These dose levels resulted in clinically relevant exposures of 2.5 to 20-fold greater than the recommended human dose, based on Cmax.
Population pharmacokinetic analysis suggests that based on Cmax and AUC, 90% of steady state in Cushing's disease patients is reached after approximately 1.5 and 15 days, respectively.
Pre- and post-natal development of Sprague-Dawley rats was not affected at exposures of about 135-times the human exposure(based on Cmax).
Based on Cmax values in rats the systemic exposure in these parenteral studies was approximately 3.5 times higher than the maximum achievable exposure after inhalation.
Vildagliptin Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg(7- fold human exposure based on Cmax).
The systemic exposure based on Cmax and AUC for free aflibercept were approximately 200- and 700-fold higher, respectively, when compared to corresponding values observed in humans after an intravitreal dose of 2 mg.
A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development at exposures approximately 135-fold the human exposure(based on Cmax).
In volunteers with moderatehepatic impairment(Child Pugh B), exposure was 7.6-fold higher based on Cmax(90% CI 4.4- 13.2) and 8.7-fold higher(90% CI 5.7- 13.1) based on AUC, respectively, compared to healthy volunteers.
At the No Observed Adverse Effect Level(NOAEL) of 0.5 mg/eye in monkeys the systemic exposure was 42- and56-fold higher based on Cmax and AUC, respectively.
At the 0.1 mg/kg dose,the systemic exposures based on Cmax and cumulative AUC for free aflibercept were approximately 17- and 10-fold higher, respectively, when compared to corresponding values observed in humans after an intravitreal dose of 2 mg.
Co-administration with the potent P-gp inhibitor ketoconazole increased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Two-year carcinogenicity studies with erlotinib conducted in rats and mice were negative up to exposures exceeding human therapeutic exposure(up to 2-fold and10-fold higher, respectively, based on Cmax and/or AUC).
In a drug-drug interaction study with the potent P-gp inducer rifampicin,exposure to nintedanib decreased to 50.3% based on AUC and to 60.3% based on Cmax upon co-administration with rifampicin compared to administration of nintedanib alone.
In a 26-week cynomolgus monkey study,hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody in cynomolgus monkeys(0.7-6 times the clinical exposure based on Cmax and AUC at steady state after weekly administration of 5, 25, and 50 mg/kg).
Trametinib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake(NRU)assay at significantly higher concentrations than clinical exposures(IC50 at 2.92 µg/ml,≥130 times the clinical exposure based on Cmax), indicating that there is low risk for phototoxicity to patients taking trametinib.
In a small parallel group design study in Japanese patients with IPF(13 patients received nintedanib on top of chronic treatment with standard doses of pirfenidone; 11 patients received nintedanib alone),exposure to nintedanib decreased to 68.3% based on AUC and to 59.2% based on Cmax upon co- administration with pirfenidone pirfenidone compared to administration of nintedanib alone.
AUC(0-) and Cmax based on population PK post-hoc estimates.
A- AUC(0-) and Cmax based on population PK post-hoc estimates.
AUC(0-) and Cmax based on population PK post-hoc estimates at the highest dose in the data for each patient.