| The route to a new drug is long and costly. Time
and money saved along the way by improving processes is inevitably valuable.
Bearing in mind that many of the drugs that fail at a late stage do so for
reasons of bioavailability, it is potentially even more important to be able to
predict problems early in development and either ‘develop them out’ or move
on to more promising candidates. In this environment, companies are well advised
to invest more time and analysis in earlier stages of clinical development in order
to reduce costly late-stage failures. This article examines how getting a candidate
into the clinic early can pay dividends, and reports on a new approach (and
new technology) that is giving drug developers a solid platform on which to
base their decisions.
THE HOLY GRAIL:
‘ONCE-A-DAY DOSING’
Oral drug administration and simplified
dosing regimens, ideally once-a-day,
that affect patient acceptability and
improve compliance, present significant
development hurdles, with many candidate
compounds still exhibiting less than ideal
pharmacokinetics. A modified release
(MR) dose form is often required. |
