Under Project Optimus, the FDA now expects oncology sponsors to evaluate multiple clinically relevant doses using the totality of the evidence and to identify the dosage that “m ...
FDA’s Project Optimus shifts oncology dosing from MTD to balancing efficacy and safety via metrics like Net Treatment Benefit to pick doses.
Michelle Dennis, QC Microbiology Application Specialist with MilliporeSigma and member of the PDA Week 2026 planning ...
The adoption of daratumumab represents a major achievement in the application of delivery technologies, specifically the ...
Scale-up involves increasing pump sizes, reactor volumes, and flow rates—but the process control logic and system ...
Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP). Sat down with ...
Ryan Murray, ValSource, breaks down far UVC technology, holistic contamination control strategies, and environmental ...
Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda, spoke with PharmTech about ...
The pharmaceutical industry is navigating one of its most disruptive periods in recent memory, according to Anthony Lakavage, ...
France’s Saint‑Julien site adds a bioprocess development suite for upstream/downstream scale-up of recombinant proteins, ...
Regulatory pressure from GxP, 21 CFR Part 11, and AI/ML guidance elevates requirements for audit trails, data lineage, ...
By incorporating these advanced models into preclinical packages for the FDA, researchers can provide a much stronger proof ...
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