An Industry Perspective on Key Considerations for the ICH S13 Guidance: Nonclinical Safety Evaluations of Oligonucleotide-Based Therapeutics
Jennifer D. Sisler(Eli Lilly (United States)), Tod A. Harper(Amgen (United States)), Helen L. Lightfoot(Roche (Switzerland)), Joel D. Parry(Age UK), Justin D. Schumacher(Bristol-Myers Squibb (Germany)), Onyi Irrechukwu(Johnson & Johnson (Israel)), Anna Westlind Johnsson(AstraZeneca (Netherlands)), Patrik Andersson(AstraZeneca (South Korea)), Sucheta Mukherjee, Yi Yang(Chinese Academy of Sciences), Alan Brown(Novartis (China)), Carole E. Harbison(Harvard University)
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