We adopted a PopPK modeling and simulation approach to predict a fixed (non body-weight-adjusted) dose of s.c. trastuzumab that could be adminon body-weight-adjustednon body-weight-adjusteddoseiteria fof dos.c.electrastuzumab
To identify a fixed dose of s.c. trastuzumab that could be administered without a loading dose, the PopPK model was used to simulate the pharmacokinetic profile for four different fixed s.c. doses (400, 500, 600, and 700 mg, all Q3W), which were compared with those obtained from simulations for the reference i.v. regimen (8 mg/kg loading dose, 6 mg/kg maintenance doses, Q3W).
We therefore used population pharmacokinetic (PopPK) modeling and simulation to predict a fixed dose of trastuzumab that could be administered without a loading dose.
While a formal maximum tolerated dose for nelfinavir was never established in HIV patients, a dose escalation trial in patients with solid tumors reports that 2 × 4250 mg nelfinavir could safely be administered without reaching a maximum tolerated dose, and 10 15 μℳ (mean 12.5 μℳ) nelfinavir peak plasma level were measured at the 3000 mg bid dose level.
Compared with the maximum tolerated dose of 425 scFv -ETA' (1.0 mg kg−1) (Bruell et al, 2005), a dose of 425 scFv -ETA' EGF-MAP could be administered without adverse effects and a lethal dose was not reached.
During the development of novel anticancer drugs, phase I trials are conducted with the objective of identifying the maximum tolerated dose (MTD) – the maximum dose that can be administered without an unacceptably high risk of toxicity.
Early results in a limited number of patients show that these cell doses may be administered without adverse events and possibly without inducing GvHD.
As a result higher radioactivity doses can be administered without risk of nephrotoxicity.
A single-dose vaccine that can be administered without water would be much easier to deliver.
The maximal doses of lipids, which can be administered, without drug substance, will be probably significantly higher.
