Spring Intro 2023

06/03/2023

• Single dose • Repeat dose ● Generally 1-3 months but can be 6 months for chronic use ● Short term use / acute life threatening – 2 weeks ● Potential to cover safety pharmacology parameters under general toxicology • Genotoxicity / Carcinogenicity ● Not required unless cause for concern • Reproductive toxicity ● Assess on case by case basis ● Limit use of non-human primates • Pharmacokinetics ● Standard ADME studies not required Preclinical testing

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Clinical Efficacy & Safety

ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION

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