Industry Perspective on First-in-Human and Clinical Pharmacology Strategies to Support Clinical Development of T-Cell Engaging Bispecific Antibodies for Cancer Therapy.

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第一作者： Prathap,Nagaraja Shastri

第一单位： Clinical Pharmacology and Pharmacometrics, Johnson and Johnson Innovative Medicine, Spring House, Pennsylvania, USA.

作者： Prathap,Nagaraja Shastri ^[1] ; Nirav,Shah ^[1] ; Martin,Lechmann ^[2] ; Hardik,Mody ^[3] ; Marc W,Retter ^[4] ; Min,Zhu ^[5] ; Tommy,Li ^[6] ; Jun,Wang ^[7] ; Naveed,Shaik ^[8] ; Xirong,Zheng ^[9] ; Meric,Ovacik ^[10] ; Fei,Hua ^[11] ; Vibha,Jawa ^[9] ; Christophe,Boetsch ^[12] ; Yanguang,Cao ^[13] ; John,Burke ^[11] ; Kaushik,Datta ^[14] ; Kapil,Gadkar ^[10] ; Vijay,Upreti ^[15] ; Alison,Betts ^[16]

作者单位： Clinical Pharmacology and Pharmacometrics, Johnson and Johnson Innovative Medicine, Spring House, Pennsylvania, USA. ^[1] Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Munich, Penzberg, Germany. ^[2] Clinical Pharmacology, Genentech, South San Francisco, California, USA. ^[3] Preclinical PK/PD, Regeneron Pharmaceuticals, Tarrytown, New York, USA. ^[4] Clinical Pharmacology, Regeneron Pharmaceuticals, Tarrytown, New York, USA. ^[5] Clinical Pharmacology, Genmab, Plainsboro, New Jersey, USA. ^[6] Biotherapeutics Discovery Research, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, Connecticut, USA. ^[7] Clinical Pharmacology, Pfizer Oncology Development, San Diego, California, USA. ^[8] Clinical Pharmacology, Pharmacometrics and Bioanalysis, Bristol Myers Squibb, Princeton, New Jersey, USA. ^[9] Preclinical PK/PD, Genentech, South San Francisco, California, USA. ^[10] Certara Predictive Technology, Certara, Concord, Massachusetts, USA. ^[11] Roche Pharma Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center Basel, Basel, Switzerland. ^[12] Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA. ^[13] Nonclinical Safety, Bristol Myers Squibb, Princeton, New Jersey, USA. ^[14] Clinical Pharmacology, Modeling & Simulation, Amgen, South San Francisco, California, USA. ^[15] Preclinical & Translational Sciences, Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA. ^[16]