Module 3 2019

Preclinical Studies

➢ Need for drug substance (and a delivery system!) ➢ ‘Relatively Dirty Batches’ needed to qualify impurity levels (ICH norms) ➢ Can require lots of drug especially for long term studies so stability data needed ➢ Long term studies (6m toxicity & carcinogenicity) ideally done on commercial route drug substance (should avoid surprise impurities late on)

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