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Accelerating NDA filing through faster carcinogenicity assessment

Drug Discovery World

Regulatory agencies such as the US Food & Drug Administration (FDA), European Medicines Agency (EMA), and the China National Medical Products Administration (NMPA) adhere to these guidelines and require that novel small molecule compounds intended for continuous or intermittent use undergo specific types of carcinogenicity testing studies.

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What to expect from PEGS Europe 2023: Day 2

Drug Discovery World

Benjamin Hackel, PhD, Professor, Chemical Engineering & Materials Science, University of Minnesota, on: ‘Engineering hyperstable synthetic miniproteins as developable ligands’. James Cooke, PhD, Associate Director, Bicycle Therapeutics, on: ‘Engineering bicyclic peptides for precision targeted medicine’.