Early phase clinical development specialist reports more and more pharmaceutical and biotechnology companies commiting to human drug absorption studies
Early phase clinical development specialist Pharmaceutical Profiles is reporting one of its busiest ever periods, as more and more pharmaceutical and biotechnology companies commit to human drug absorption (HDA) studies.
The company believes the significant increase in activity could be one of the first signs that the global pharmaceutical industry is emerging from the low ebb of the past two years and is committing to the types of innovative study design that can help them make the right product development decisions in early clinical development.
HDA studies provide a vital understanding of intrinsic drug absorption and can be used to probe absorption mechanisms known directly to influence oral bioavailability.
Through custom study design, it is possible to assess the relative contributions of in vivo dissolution, permeability, intestinal efflux and gut-wall metabolism on oral availability in the various regions of the human GI tract.
The data gained from HDA studies assists pharmaceutical and biotechnology companies to make key decisions, especially in consideration of sophisticated delivery systems to support the development of new molecular entities and in the life cycle management of marketed drugs.
In the last six months, the company says it has seen a huge increase in customers committing to such studies.
Much of the work is coming from the major United States-based pharmaceutical companies, but there is also significant activity from United Kingdom and European companies. "We are being inundated with enquiries and firm commitments to carry out HDA studies," explained business development director Paul Clewlow.
"This is quite distinct from the early part of the year and it looks sustainable.
"Throughout the economic downturn we continued to heavily promote the utility of HDA studies in early development.
"It's clear that the major players are putting the global economic troubles behind them and committing to research and development investment. "As a consequence, human drug absorption studies like those we undertake, are one area where there has been a large increase in activity.
"There is a real 'log jam' at Phase I/IIa and the revolutionary studies we offer help pinpoint the right products to take through into later phase development and onwards to market".
