FIH dose selection beyond MABEL: Optimizing phase 1 clinical trial starting dose whilst protecting patient safety

Mineo Matsumoto(Pharmaceuticals and Medical Devices Agency), Jean Sathish(Pfizer (United States)), Payal Arora(Utrecht University), Cris Kamperschroer(AVEO Oncology (United States)), Kaushik Datta(Bristol-Myers Squibb (Germany)), Suresh Kumar Swaminathan(Janssen (United States)), Rutwij Dave(Gilead Sciences (United Kingdom)), Mizuho Suzuki(Pharmaceuticals and Medical Devices Agency), Christine E. Crute(Health and Environmental Sciences Institute), Zheng Yang(Somerville Hospital), Smita Salian-Mehta(Gilead Sciences (United States)), Marie C. Fortin(Rutgers, The State University of New Jersey), Masanori Hiura(Kyowa Kirin (Japan)), J.Ryan Polli(Novartis (Switzerland)), Frank R. Brennan(AstraZeneca (United Kingdom))
Regulatory Toxicology and Pharmacology
January 30, 2026
Cited by 0


Related Papers