RE: PYC AI tool publication In Frontiers6 Sep 2023 06:36
Well worth a read,this was published in relation tk the new FDA guidelines called 'Project Optimus " and was from the PYC RNS in April 2023
Here is the first paragraphs
Should personalised dosing have a role in cancer treatment?
Claire C. Villette David Orrell Jim Millen Christophe Chassagnole*
Physiomics PLC, Oxford, United Kingdom
Almost all pharmaceutical products are approved on the basis of their effect in patients representing the “average” of the population studied in registrational trials, with most drug labels allowing, at most, for empirical dose reduction in the case of toxicity. In this perspective article we explore some of the evidence that supports the use of personalised dosing in cancer treatment and show how we have been able to build on existing models linking dose, exposure and toxicity to demonstrate how dose optimisation, including increasing the dose, has the potential to significantly improve efficacy outcomes. We also explore, through the lens of our own experience of developing a personalised dosing platform, some of the hurdles that stand in the way of implementing a personalised approach to dosing in real world settings. In particular, our experience is illustrated by the application of a dosing platform for docetaxel treatment in prostate cancer.
1 Introduction
Drug development is a notoriously expensive and risky business. It is estimated that it costs around a billion dollars, from initial design to final patient trials, to develop a successful new treatment (1). The vast majority of new candidates of course do not get this far. And even if a drug does make it to market, the actual improvement that it offers over existing treatments may not be very great