Biopharmaceutics, formulations and exposure

Abstract

While the mantra for exciting drug discovery is target,
medicinal chemistry, and in vitro/in vivo biology, the
early drug development success leading to a positive
clinical proof of concept studies is largely predicated by
biopharmaceutics, formulations, and drug exposure. As
it is largely an unchartered territory when it comes to
novel chemical entities (NCEs), the skills of a formulator
to be practical, pragmatic, and innovative would be put
to a litmus test. This is because the success of delivering
and maximizing the exposure in humans is dictated
by the chosen formulation options to overcome the
biopharmaceutical challenges imposed by the NCE.
The editorial is written in the context of providing
perspectives on “Biopharmaceutics, Formulations and
Exposure†that are key to make an informed decision
on the developability aspects of the compound as it is
declared a “drug candidate†and enters the challenging
phase of drug development.