COMIC: A Bayesian Dose Optimization Design for Drug Combination in Multiple Indications With Application to CAR‐T Therapies
Sign Up to like & getrecommendations! Published in 2025 at "Statistics in Medicine"
DOI: 10.1002/sim.70107
Abstract: Project Optimus, initiated by the US Food and Drug Administration (FDA), seeks to shift the focus of dose finding and selection from the maximum tolerated dose to the optimal dose that offers the most favorable… read more here.
Keywords: combination; drug; dose optimization; multiple indications ... See more keywords
Long-Term Safety of Adalimumab in 29,967 Adult Patients From Global Clinical Trials Across Multiple Indications: An Updated Analysis
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DOI: 10.1007/s12325-019-01145-8
Abstract: Introduction The safety profile of adalimumab was previously reported in 23,458 patients across multiple indications. Here we report the long-term safety of adalimumab in adults with plaque psoriasis (Ps), hidradenitis suppurativa (HS), rheumatoid arthritis (RA),… read more here.
Keywords: multiple indications; across multiple; long term; safety ... See more keywords
M-DODII: Bayesian dose optimization design for randomized phase II study with multiple indications.
Sign Up to like & getrecommendations! Published in 2025 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2025.2589731
Abstract: The landscape of oncology drug development is transitioning from traditional cytotoxic chemotherapy drugs to novel agents, such as molecularly targeted therapies (MTA) or immunotherapies. Conventional dose optimization methods based on chemotherapy that assume a monotone… read more here.
Keywords: bayesian dose; optimization design; dose optimization; multiple indications ... See more keywords