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- [41] Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) AssessmentCLINICAL PHARMACOLOGY & THERAPEUTICS, 2021, 109 (06) : 1395 - 1415Leach, Michael W.论文数: 0 引用数: 0 h-index: 0机构: Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USA IQ MABEL Working Grp, Cambridge, MA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USAClarke, David O.论文数: 0 引用数: 0 h-index: 0机构: Eli Lilly & Co, Lilly Corp Ctr, Nonclin Safety Assessment, Indianapolis, IN 46285 USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USADudal, Sherri论文数: 0 引用数: 0 h-index: 0机构: F Hoffmann La Roche Ltd, DMPK Project Leads & Translat M&S, Pharmaceut Sci, Basel, Switzerland Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USAHan, Chao论文数: 0 引用数: 0 h-index: 0机构: Janssen Res & Dev LLC, Biol Dev Sci, Spring House, PA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USALi, Chunze论文数: 0 引用数: 0 h-index: 0机构: Genentech Inc, Dept Clin Pharmacol, San Francisco, CA 94080 USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USAYang, Zheng论文数: 0 引用数: 0 h-index: 0机构: Bristol Myers Squibb Co, Metab & Pharmacokinet, Princeton, NJ USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USABrennan, Frank R.论文数: 0 引用数: 0 h-index: 0机构: UCB Pharma, Nonclin Safety, Slough, Berks, England Novartis Inst BioMed Res, Preclin Safety, Basel, Switzerland Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USABailey, Wendy J.论文数: 0 引用数: 0 h-index: 0机构: Merck & Co Inc, Safety Assessment & Lab Anim Resources, West Point, PA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USAChen, Yingxue论文数: 0 引用数: 0 h-index: 0机构: AstraZeneca, Clin Pharmacol & Quantitat Pharmacol, Clin Pharmacol & Safety Sci, BioPharmaceut R&D, Boston, MA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USADeslandes, Antoine论文数: 0 引用数: 0 h-index: 0机构: Sanofi R&D, Ctr Rech Vitry Sur Seine 13, Translat Med & Early Dev, Vitry Sur Seine, France Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USALoberg, Lise I.论文数: 0 引用数: 0 h-index: 0机构: AbbVie, Preclin Safety, N Chicago, IL 60064 USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USAMayawala, Kapil论文数: 0 引用数: 0 h-index: 0机构: Merck & Co Inc, Quantitat Pharmacol & Pharmacometr, PPDM, Kenilworth, NJ USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USARogge, Mark C.论文数: 0 引用数: 0 h-index: 0机构: Takeda Pharmaceut, Quantitat & Translat Sci, Cambridge, MA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USATodd, Marque论文数: 0 引用数: 0 h-index: 0机构: Pfizer Inc, Drug Safety Res & Dev, San Diego, CA USA Renaissance Consulting, Escondido, CA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USAChemuturi, Nagendra V.论文数: 0 引用数: 0 h-index: 0机构: Novartis Inst BioMed Res Inc, Pharmacokinet Sci, Cambridge, MA 02139 USA Takeda Pharmaceut, Cambridge, MA 02139 USA IQ MABEL Working Grp, Cambridge, MA USA Pfizer Inc, Drug Safety Res & Dev, Cambridge, MA USA