Blood samples were drawn from the retro-orbital sinus under light isoflurane anaesthesia for determination of plasma SET-M33 levels. The samples were taken on days 1 and 28 of treatment at the following times: control group: pre-dose and 30 min; 5, 9 and 15 mg/kg/day-group: pre-dose, 5, 15, 30, 60 min and 24 h after administration. Blood samples were collected into polypropylene test tubes containing lithium heparin anticoagulant and kept at room temperature for no longer than 60 min until centrifuging (1600 g for 10 min at 2–8 °C). The plasma obtained from each sample was transferred to a fresh polypropylene test tubes, immediately frozen in dry ice and stored at − 20 °C ± 5. Plasma concentrations of SET-M33 were measured by a previously validated LC–MS/MS method. Toxicokinetic parameters were determined for mean plasma concentrations at each dose level and time point, according to the validated method and with WinNonlin software, version 6.3, in the Phoenix Suite version 1.3 (Pharsight Corporation, Mountain View, CA, USA).
Winnonlin software version 6
Manufactured by Pharsight
Sourced in United States
WinNonlin is a software tool developed by Pharsight for pharmacokinetic and pharmacodynamic data analysis. Version 6.3 is the latest release of the software. The core function of WinNonlin is to provide a platform for the analysis and modeling of drug concentration and response data obtained from clinical and preclinical studies.
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Lab products found in correlation
4 protocols using winnonlin software version 6
1
Plasma SET-M33 Pharmacokinetics in Mice
2
Pharmacokinetics of Novel Compounds in Rats
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To assess the applicability of present method, the pharmacokinetics of H002, H002-P and H002-M were investigated in male Sprague–Dawley (SD) rats after oral administration of H002 at 3, 10 and 30 mg/kg. The rats (180–220 g) were purchased from Beijing Vital River Experimental Animal Co., Ltd. All animal protocols were approved by Institute Animal Care and Welfare Committee. The rats were allowed free access to water and chow diet and fasted overnight with water before pharmacokinetic experiments.
The dosing solutions were prepared by suspending H002 in 0.5% hydroxypropyl methyl cellulose (HPMC). The rats were given H002 at dose of 3, 10 and 30 mg/kg via gavage. Blood samples were taken from each animal by orbital bleeding via capillary tubes at 5, 15, 30 min, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 h after dosing. The blood samples were placed on ice and immediately treated as described inSection 2.4 and frozen at –20 °C until analyzed.
The pharmacokinetic parameters of H002, H002-P and H002-M were calculated using WinNonlin software version 6.3 based on non-compartmental analysis (Pharsight Corporation, Mountain View, USA). The blood concentrations of the tested compounds were expressed as mean±SD.
The dosing solutions were prepared by suspending H002 in 0.5% hydroxypropyl methyl cellulose (HPMC). The rats were given H002 at dose of 3, 10 and 30 mg/kg via gavage. Blood samples were taken from each animal by orbital bleeding via capillary tubes at 5, 15, 30 min, 1, 2, 4, 6, 8, 12, 24, 36, 48 and 72 h after dosing. The blood samples were placed on ice and immediately treated as described in
The pharmacokinetic parameters of H002, H002-P and H002-M were calculated using WinNonlin software version 6.3 based on non-compartmental analysis (Pharsight Corporation, Mountain View, USA). The blood concentrations of the tested compounds were expressed as mean±SD.
3
Pharmacokinetics of IMMH-010 Maleate in Rats
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IMMH-010 maleate was suspended in 0.5% sodium carboxymethyl cellulose. The rats were intragastrically (i.g.) administered IMMH-010 maleate at doses of 10, 30, and 100 mg/kg. Blood samples were withdrawn via the orbital plexus into heparinized tubes with NaF at 5, 15, and 30 min and 1, 2, 4, 6, 8, 12, 24, 36, and 48 h. Plasma was immediately prepared by centrifugation at 5,000 rpm for 10 min. All samples were stored at −20°C prior to analysis. The PK parameters of IMMH-010 and YPD-29B were calculated using the Linear Trapezoidal with Linear Interpolation method by WinNonlin software version 6.3 based on a noncompartmental model (Pharsight Corporation, Mountain View, United States ).
4
Pharmacokinetic Evaluation of Novel Compounds
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All animal protocols
were approved by the Institute Animal
Care and Welfare Committee of Shanghai Bioduro Biologics Co., Ltd.
The selected compounds25a , 24f , and TCA1
were subjected to pharmacokinetic studies in Balb/c mice (male) weighing
26–27 g with three mice in the oral administration group and
three mice in the intravenous injection group. The tested compound
was formulated at a concentration of 5 mg/mL for a dose of 50 mg/kg
given orally (p.o.) and at 1 mg/mL for a dose of 5 mg/kg given intravenously
(i.v.). The tested compound was formulated with 0.5% carboxymethyl
cellulose for p.o. administration and with a mix solution (10%DMSO/50%poly(ethylene
glycol) (PEG)400/40%water) for i.v. administration. Blood samples
were collected at 5, 15, 30 min, 1, 2, 4, 7, 24 h after oral dosing
and i.v. administration. Plasma was harvested and stored at −80
°C until analyzed. The pharmacokinetic parameters were calculated
using WinNonlin software version 6.3 based on noncompartmental analysis
(Pharsight Corporation, Mountain View). The oral bioavailability was
calculated as the ratio between the area under the curve (AUC) following
intravenous administration corrected for dose (F =
(AUCp.o. × dosei.v.)/(AUCi.v. × dosep.o.)).
were approved by the Institute Animal
Care and Welfare Committee of Shanghai Bioduro Biologics Co., Ltd.
The selected compounds
were subjected to pharmacokinetic studies in Balb/c mice (male) weighing
26–27 g with three mice in the oral administration group and
three mice in the intravenous injection group. The tested compound
was formulated at a concentration of 5 mg/mL for a dose of 50 mg/kg
given orally (p.o.) and at 1 mg/mL for a dose of 5 mg/kg given intravenously
(i.v.). The tested compound was formulated with 0.5% carboxymethyl
cellulose for p.o. administration and with a mix solution (10%DMSO/50%poly(ethylene
glycol) (PEG)400/40%water) for i.v. administration. Blood samples
were collected at 5, 15, 30 min, 1, 2, 4, 7, 24 h after oral dosing
and i.v. administration. Plasma was harvested and stored at −80
°C until analyzed. The pharmacokinetic parameters were calculated
using WinNonlin software version 6.3 based on noncompartmental analysis
(Pharsight Corporation, Mountain View). The oral bioavailability was
calculated as the ratio between the area under the curve (AUC) following
intravenous administration corrected for dose (F =
(AUCp.o. × dosei.v.)/(AUCi.v. × dosep.o.)).
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