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Author

Avery McIntosh

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Editorial Open access Aug 2026

Clinical Pharmacology at the Point of Decision

The articles in this issue of Clinical Pharmacology & Therapeutics illustrate clinical pharmacology at points of decision, which span oncology, infectious diseases, neurology, transplantation, pharmacogenomics, regulatory science, and health-system value.

M. Elmeliegy, A. McIntosh · 0 citations
Review Open access Aug 2026

Quantitative Dose Optimization for Gene Therapy Trials: Implications for Project Optimus and Early‐Phase Design

Quantitative dose optimization in early phase clinical trials for investigational new drugs has been expanding across drug modalities and disease indications in response to the limitations of non‐quantitative or algorithmic methods of dose progression. In the context of the FDA's Project Optimus Initiative, which empha...

Kevin Roberts, Jeffrey Palmer, Jessica Volpe et al. · 0 citations

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