Abstract

François-Xavier Lacasse*

ABSTRACT

Over the last decades, timelines to enter into Phase I clinical trials are becoming increasingly shorter as companies seek definitive results that would prove or disprove their drug’s potential. In parallel, drug substances became more and more difficult to formulate due to their poor biopharmaceutical properties (solubility, permeation, absorption and bioavailability). Formulation development has become the crux of the matter to develop a formulation that will be stable, reliable, and where it will represent, as much as possible, an almost final formulation. More precisely it means that formulated dosage form should not generate the carrying out of comparative bioavailability studies between the clinical phases, to narrow down the cost and especially the time of development. Quality by design (QbD) became a powerful tool to achieve this goal with success and has already demonstrated its reliability not only with marketed products but also at the early stage of development where, most of the time formulation development is step that has been (and still is) plus or less neglected because of the lack knowledge in that domain.