Module 9 2024

03/09/2024

Pre-Clinical Testing of Biologicals

• Safety testing of biologicals is inevitably complicated by the common mismatch between test article specificity, selection of test species, dose, route of administration, duration of exposure, immunogenicity and so on

• Another perfect example of the case by case basis applies here in a situation where guidance can really only aim to be indicative rather than definitive

The Organisation for Professionals in Regulatory Affairs

53

Clinical Development of Biopharmaceuticals

Day 1: Lecture 3

With

Tara Hutton

The Organisation for Professionals in Regulatory Affairs

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