ENP Newswire -
Release date- 15072014 - Industry is always looking for ways to increase the accuracy and efficiency of the research and development process.
Physiologically-based pharmacokinetic (PBPK) modelling and simulation is a tool that can help to improve this process. We explored its applications at the
One way that industry is innovating to improve research and development (R&D) is in modelling and simulation, which plays an important part in the drug development process. Although the concept has been around for some time, PBPK is an emerging technique that is rapidly gaining traction within the pharmaceutical industry. Its many diverse applications enable it to be used throughout the R&D process, from informing study design and first-in-man dose selection to modelling trial results in paediatric studies. However, this area currently lacks the regulatory guidance required to support and develop its use.
The timely nature of this meeting is reflected in the publication of the EMA concept paper on PBPK, now open for consultation.
Director of R&D Policy
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