Service designed to maximise the data obtained from 'standard' clinical studies in healthy volunteers has been launched by an early phase drug development specialist
A new service designed to maximise the data obtained from 'standard' clinical studies in healthy volunteers has been launched by an early phase drug development specialist, Pharmaceutical Profiles.
The new service - called PKPlus - combines in a single Phase I pharmacokinetic and pharmacodynamic drug evaluation with the company's extensive knowledge of the regional absorption of orally-administered pharmaceutical products, through its human drug absorption study service, and its exclusive experience with the Enterion capsule.
PKPlus maps drug absorption throughout the human gastrointestinal tract to provide data which is often pivotal to understanding the biopharmaceutical properties of the drug, what may limit its oral bioavailability and what might consequently be the most effective approach to its delivery through formulation development.
Any drug potentially requiring technologies such as sustained or extended release, pulsed release, gastroretention, colon targeting, solubility or permeability enhancement or CYP3A4 or Pgp inhibition could benefit from the process offered by the new PKPlus service.
Classical Phase I studies, such as rising dose safety and absolute oral bioavailability, are studies where the PKPlus approach could add considerable value.
For example, absolute oral bioavailability is measured in a two-way crossover study comparing an oral immediate release dosage form versus intravenous administration as a reference.
However, by adding one or more targeted drug deliveries to key intestinal regions using the Enterion capsule, detailed information on regional absorption of the drug can be obtained very cost-effectively and this additional data can be used to guide future product development. "Bioavailability studies are essential to drug development and form an integral part of the registration dossier," explained Paul Clewlow, Business Development Director, "To formally characterise and assess the pharmacokinetic (PK) performance of almost every oral product, worldwide regulatory authorities demand specific studies in healthy volunteers. "Such studies typically take place throughout the development cycle, ranging from early single dose and absolute oral bioavailability investigations, through steady state and food effect studies and finally to the evaluation of specific drug interactions." "Results from PK studies ultimately affect how the product is prescribed and so underpin its safe and efficacious use.
However, they by no means provide a complete picture of the drug's biopharmaceutical properties.
Today, many of the compounds exiting drug discovery and embarking on the winding road of product development have highly complex biopharmaceutical properties." "The secret to successful and cost-effective product development is gathering as much information as possible from the standard clinical studies that have to be undertaken en route to regulatory filing.
Much of the cost of undertaking a human PK study is 'fixed' and essentially independent of the size and complexity of the study design.
Consequently, significant added value can be achieved by designing the study to answer multiple questions, rather than just one.
That's the reasoning behind our new PKPlus service."
