Examples of using Based on cmax in English and their translations into Bulgarian
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A average increases of 47% in AUC and73% in Cmax b based on Cmax and AUC.
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.
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.
The median accumulation between first and 35th dose was 3.71X(based on AUC ratio)and 3.90X(based on Cmax ratio).
In volunteers with moderate hepatic impairment(Child Pugh B),exposure was 7.6-fold higher based on Cmax(90% CI 4.4- 13.2) and 8.7fold higher(90% CI 5.7- 13.1) based on AUC, respectively, compared to healthy volunteers.
Pre- and post-natal development of Sprague-Dawley rats was not affected at exposures of about 135-times the human exposure(based on Cmax).
Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life.
Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg(7fold 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.
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).
Based on Cmax and AUC for free aflibercept observed at the 3 mg/kg intravenous dose, the systemic exposures were approximately 4,900-fold and 1,500-fold higher, respectively, than the exposure observed in humans after an intravitreal dose of 2 mg. All changes were reversible.
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 a dedicated single dose phase I study and compared to healthy subjects,exposure to nintedanib based on Cmax and AUC was 2.2-fold higher in volunteers with mild hepatic impairment(Child Pugh A; 90% CI 1.3- 3.7 for Cmax and 1.2- 3.8 for AUC, respectively).
Thus, in addition to altered acyclovir pharmacokinetics in renal impairment,this factor also needs to be taken into account in developing dosage adjustments based on Cmax and/or AUC.
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.
Lusutrombopag has no phototoxic potential in the skin phototoxicity study in hairless mice at doses up to 500 mg/kg(96.3 µg/mL)(613 times the human clinical exposures in adults based on Cmax[0.157 µg/mL]).
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.
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).
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.
Changes in blood pressure and heart rate, and QRS complex andPR interval were also observed in animals after acute dosing(approximately 2.6 times the human clinical exposure at 100 mg after a single dose 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 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.
The incidences of embryo-foetal loss were 33, 50, and 85% 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 andattributed 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).
In addition, cardiovascular effects(QTc prolongation, decreased heart rate, and increased RR interval andsystolic blood pressure) were identified in telemetered dogs at≥4 times human clinical exposure based on Cmax.
Steady state was achieved within 5 days following repeated twice daily dosing, and abemaciclib accumulated with a geometric mean accumulation ratio of 3.7(58% CV) and5.8(65% CV) based on Cmax and AUC, respectively.
Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats(micronucleus and unscheduled DNA synthesis, 10 times or 8 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and7 times the human clinical exposure in HCV patients at 100 mg/day, based on Cmax).
In healthy subjects, co-administration of abemaciclib and the P-glycoprotein(P-gp)substrate loperamide resulted in an increase in loperamide plasma exposure of 9% based on AUC0-∞ and 35% based on Cmax.
However, weekly obinutuzumab dosing from post-coitum day 20 to delivery resulted in complete depletion of B-cells in infant monkeys at weekly intravenous obinutuzumab doses of 25 and50 mg/kg(2-5 times the clinical exposure based on Cmax and AUC).