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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

MAY 10, 2023

Carcinogenicity testing For decades, the two-year rodent bioassay has been the regulatory standard used to determine the carcinogenic potential of new drugs. This process historically involved lifetime carcinogenicity bioassays in two species. Figure 1: Comparing Carcinogenicity Testing Timelines in Transgenic vs. Standard Mice.

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Bioassay Genotoxicity Drugs In-Vivo 52
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What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

NOVEMBER 9, 2023

Advances in analytical techniques and approaches This session is made up of four presentations which include: Christian Graf, PhD, Fellow, Scientific Office, Novartis TRD Biologics, on: ‘MS-based cell bioassays: A novel tool for biotherapeutics characterisation’. The session ends with two presentations and two luncheon presentations.

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Engineer Antibody Protein In-Vivo 52
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