| Increasing pressure is being placed on the pharmaceutical
industry to limit the costs and time associated with delivering
a drug to the market. First-in-human and other early phase
studies are a critical step in the complex process. Normally
limited to objectives based around pharmacokinetics, safety
and tolerability, early phase studies provide an underutilised
opportunity to obtain valuable pharmacodynamic data regarding
a drug’s mechanism of action, pharmacological activity and
potential dosing regimens. Carefully chosen biomarkers are
able to be easily incorporated into early phase drug studies
and provide guidance for important decisions concerning
a drug’s future.
Analyses show that the largest part of the development costs
are spent on failures, particularly in the latter part of the
process because of the high costs of large-scale clinical
trials (1,2). Consequently, there is much pressure on the drug
development process to ‘kill failures early’ by showing that the
compound does not have the characteristics of a proper drug –
or vice versa – and preferably to show that it does (3). Thus,
drug development has become a much more continuous process
than is suggested by the ‘classic’ separation into distinct
phases. In fact, modern ICH guidelines, as implemented
by the regulatory authorities, stipulate the intelligent use
of pharmacodynamic drug effect measurements during all
stages of development (4-6). |
