The assumptions, diagnostics, and context of use are not details. They are the substance of the analysis. A poorly constructed model, applied without evaluation, without documented assumptions, without a defined context of use, is not a model at all. It is a number with a confident face. And a number with a confident face has no place in a development decision.

From accelerated approval to voluntary withdrawal, the ibrutinib story is one of the most instructive case studies in modern regulatory science. In my latest blog post, I trace a decade of regulatory decisions, confirmatory trial choices, shifting competitive landscapes, and the lessons they leave behind for anyone working in drug development. A particularly great read for those starting their journey in clinical pharmacology.

FDA's new guidance on QSP for first-in-human dose selection looks like a methods update. It's actually the agency closing an eighteen-year gap, one that traces back to a London hospital in 2006 and a lesson the rest of the industry already knew.

Most companies bring in a Quantitative Clinical Pharmacologist too late. This article explains why the non-clinical phase is the critical window for PKPD modelling and clinical pharmacology expertise, and how early investment in human dose prediction shapes formulation, toxicology, candidate selection, and regulatory strategy.