A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Abstract

This research suggests that FDA dosing recommendations may lead to efficacy trial dosing regimens that are more likely to enable individualized dosing in labeling.

Precision Dosing: The Clinical Pharmacology of Goldilocks

“…It would also give her the option to titrate up to the desired effect if needed. This is a recognised precision dosing strategy for some drugs and one that regulatory authorities support and indeed encourage when appropriate 11 . It is encouraging that such strategies are used but also noteworthy that there are many suitable cases where they are not.…”

“…This is a recognised precision dosing strategy for some drugs and one that regulatory authorities support and indeed encourage when appropriate. 11 It is encouraging that such strategies are used but also noteworthy that there are many suitable cases where they are not. Given the urgency of Goldilocks' situation though, there was probably limited time for her to explore dose titration so it is to be hoped she adopted a model-informed approach to identify the right dose for her, based on her previous experience of how the differences in the three bears preferences affected her.…”

“…Current drug labels are often inadequate to support precision dosing for many drugs, and some relatively simple changes could help increase the acceptance and use of precision dosing. 19 Regulatory authorities recognise the value that precision dosing can bring for some drugs 11 and a recent FDA workshop brought together many interested parties from academia, industry, patients, and the health authorities, delivering some critical viewpoints and ideas to increase uptake. 20 Ideally, model-informed precision dosing will be built into drug development for those drugs where it is most likely to be useful.…”