Examples of using Based on cmax in English and their translations into Slovenian
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In younger patients 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 to20-fold greater than the recommended human dose, 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.
Pre- and post-natal development of Sprague-Dawley rats was not affected at exposures of about 135-times the human exposure(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.
At the No Observed Adverse Effect Level(NOAEL) of 0.5 mg/eye in monkeys the systemic exposure was 42- and 56-fold higher based on Cmax and AUC, respectively.
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.
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).
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.
A study in Sprague-Dawley rats showed no adverse effects on embryo-fetal development atexposures approximately 135-fold the human exposure(based on Cmax).
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 ketoconazoleincreased exposure to nintedanib 1.61-fold based on AUC and 1.83-fold based on Cmax in a dedicated drug-drug interaction study.
Exposure in multiple myeloma patients is slightly higher based on Cmax and AUC values as compared to healthy male volunteers since the clearance/bioavailable fraction of a drug(CL/F) in multiple myeloma patients is lower(approximately 200 ml/min compared to 300 ml/min) than it is in healthy volunteers.
For pregnant female monkeys treated with bi-weekly pertuzumab doses of 10, 30, and 100 mg/kg,respectively(2.5 to 20-fold greater than the recommended human dose, based on Cmax).
In a 26-week cynomolgus monkey study, hypersensitivity reactions were noted and attributed to the foreign recognition of the humanised antibody incynomolgus 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).
In a perinatal/postnatal reproduction study in pregnant rats treated with amifampridine, a dose-related increase in the percentage of mothers with stillborn offspring(16.7%-20%) was observed at 22.5 mg/kg/day and 75 mg/kg/day(1.1 and2.7 times the 80 mg per day dose in humans based on Cmax).
Trametinib was phototoxic in an in vitro mouse fibroblast 3T3 Neutral Red Uptake(NRU) assay at significantly higher concentrations than clinical exposures(IC50 at2.92 µg/ml,≥130 times the clinical exposure based on Cmax), indicating that there is low risk for phototoxicity to patients taking trametinib.
Two-year carcinogenicity studies with erlotinib conducted in rats and mice were negative up to exposures exceeding human therapeutic exposure(up to 2-fold and 10-fold higher,respectively, based on Cmax and/or AUC).
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.
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.
The net effect of these changes after seroconversion wasan increase in exposure of 2- to 3-fold based on AUC and Cmax.
Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold,respectively, based on comparison of Cmax values at the No Observed Effect Level(NOEL) with the Cmax achieved on dosing with 6 mg/ kg once daily in patients with normal renal function.
In direct comparison, requirements for bioequivalence are met for Tresiba 100 units/mL andTresiba 200 units/mL(based on AUCIDeg, τ, SS and Cmax, IDeg, SS).
Based on in vitro IC50 and in vivo plasma Cmax values, pazopanib metabolites GSK1268992 and GSK1268997 may contribute to the net inhibitory effect of pazopanib towards BCRP.
In 49 paediatric patients receiving the equivalent of a 600 mg dose ofefavirenz(dose adjusted from calculated body size based on weight), steady state Cmax was 14.1M, steady state Cmin was 5.6M, and AUC was 216M·h.
Population PK analysis based on sparse sampling indicated no clinically significant interaction effect on AUC and Cmax of the CYP2D6 substrate desipramine.
Paediatric pharmacokinetics: in 49 paediatric patients receiving the equivalent of a 600 mg dose ofefavirenz(dose adjusted from calculated body size based on weight), steady state Cmax was 14.1 μ M, steady state Cmin was 5.6 μ M, and AUC was 216 μ M·h.