Sentence examples for based on preclinical data from inspiring English sources

The starting dose was 100 mg BID, which was selected based on preclinical data in rodents (one-third of the toxic dose low and one-tenth of the dose causing severe toxicity in rat) and a preceding study in healthy male volunteers.

We undertook this study of the protein deacetylase inhibitor Romidepsin in chemosensitive recurrent SCLC based on preclinical data that suggested this to be an active target.

For a new chemical entity (NCE) with a novel pharmacological mechanism, the only guidance for selection of study population and doses is often based on preclinical data.

However, our ability to predict the clinical efficacy of a new compound in the clinic based on preclinical data is still limited.

The open label data extends the treatment experience to patients with migraine without aura and chronic migraine, doing so based on preclinical data [15, 19], and interestingly the results seem broadly comparable.

Based on preclinical data indicating the radiosensitizing potential of epothilone B, the present study was designed to evaluate the toxicity and response rate of patupilone, an epothilone B, with concurrent radiotherapy (RT) for the treatment of central nervous system malignancies.

The model structure and numerous parameterizations representing different virtual subjects were developed based on preclinical mechanistic data and calibrated to clinical data on: untreated subjects; LDLc lowering by statins; and RG7652 PK and effects on total PCSK9 and LDLc in single-administration treatment in the phase I trial.

This fact needs to be considered when applying for first-in-human studies based on preclinical biokinetic data scaled to human anatomy.

Physiologically-based pharmacokinetic (PBPK) modeling can aid in understanding mechanisms of tissue uptake and can predict, by means of inter-species scaling, tissue concentrations of therapeutic antibodies in humans based on preclinical PK data of molecules currently in development [13].

A dose of 400 mg (250 mg m−2) was predicted to achieve meaningful plasma concentrations (>10  μ M) based on preclinical PK data, and a single-dose human study demonstrated that the elimination half-life was suitable for twice daily administration, although the interindividual variability in clearance was high (De la Motte and Gianella-Borradori, 2004).

The schedule selected for phase II evaluation is the every other day schedule, in part because both achieved the same recommended dose and the every other day schedule seemed to have less symptomatic toxicity, but also because more continuous exposure might provide better therapeutic efficacy, based on preclinical schedule data.