Rise attributed to better understanding within the major pharmaceutical companies of the ways in which innovative early phase trials can enhance the decision-making process
Phase I/IIa clinical research organisation Pharmaceutical Profiles has reported significant increases in demand during the second half of 2003 for its specialist service of human drug absorption (HDA) studies.
The company believes a 250% percentage increase in orders received compared to the same period in the last financial year can be accounted for not only by improved trading conditions in the United States, increased R and D budgets and a greater level of confidence, but also a better understanding within the major pharmaceutical companies of the ways in which innovative early phase trials, like HDA studies, can provide more data, early in product development, to enhance the decision-making process.
As many as one in three drugs fail in Phase I clinical testing despite extensive pre-clinical screening of potential clinical candidates; mainly because of the lack of predictive power of drug candidate performance in man. "The message we give depends on the audience we are talking to," commented Pharmaceutical Profiles's Paul Clewlow. "But the feedback remains the same, there is an increasing interest in human drug absorption studies and how they can provide a vital understanding of intrinsic oral drug absorption in humans.
"The data gained from HDA studies assists pharmaceutical and drug delivery companies to make key decisions, especially when choosing the right delivery technologies to support the development of new molecular entities, entering the clinic for the first time, and in the life cycle management of marketed drugs.
"The industry seems to have emerged from the doldrums and now has a refreshing new approach to using innovative technologies like those offered by Pharmaceutical Profiles".
Pharmaceutical Profiles is at the forefront of early clinical drug development.
It is unique in having a custom built facility incorporating a GCP clinical research and medical imaging unit and GMP manufacturing facilities and laboratories near Nottingham in the United Kingdom, as well as operations in the United States and Asia.
The firm now plans to build on its success in the USA with further recruitment and expansion of its US operations.
