RAD001 and vehicle aliquots were thawed 10-30 min before dosing animals and unused portions were discarded.
The intravenous administration of 2.5 mL/kg Cremophore® EL, 10 min before dosing of either doxorubicine or doxorubicinol has resulted in doubling of AUC and Cmax and reduction of clearance to half for both the drugs.
Trough FEV1 was defined as the mean of the two pre-treatment FEV1 values (at 1 h and 10 min before dosing, respectively) at the end of the dosing interval, and baseline FEV1 was defined as the mean of the two pre-treatment FEV1 values (1 h pre-dose and 10 min pre-dose) measured prior to administration of the first dose of study medication.
Blood samples were collected at baseline (within 60 min [study 1] or 90 min [study 2] before dosing), every 2 h until 32 h postdose, and at hours 36, 48, 72, 96, 120, 168, 216, 264, and 336 postdose.
Serum samples for monitoring ADA were collected from all patients at 30 min before dose in each cycle, at the end of study, and during follow-up visits.
The samples were taken immediately before dosing, 30 min and 1, 1.5, 2, 3, 4, 6, 8 and 10 h after administration of the drug on days 1 and 4 (or 5) of the first and second courses.
On the first morning of each treatment period, subjects performed the PD tests immediately before dosing and at 10 min [visual analog scale (VAS) only], 20 min, 1, 1.5, 2, 2.5, 3, 4, and 5 h post-dose.
Patients who received SC placebo during period II were randomised (1 1) to receive either an intravenous placebo or intravenous abatacept loading dose (approximately 30 min before SC abatacept dosing at the beginning of period III (day 169)) to determine whether the administration of the intravenous abatacept loading dose affected immunogenicity upon reintroduction.
Video-EEG recordings of baseline activity in the freely moving rats began at least 10 min before oral dosing of RDX.
Subjects were given a light standard meal (∼200 kcal with 8 g fat) 30 min before each drug dose and were allowed to eat 4 h after administration of the study drug.
A single administration of morphine 30 min before surgery dose-dependently (0.1 3 mg/kg, s.c).
