Module 9 2021

22/03/2021

HOW MUCH CLINICAL DATA?

Non Clinical and Clinical Guideline (EMEA/CHMP/BMWP/42832/05) Usually comparative clinical trials required Safety data must be sufficient Clinical comparability margins should be prespecified and justified, primarily on clinical grounds Assay sensitivity (see ICH topic E10) has to be ensured If a clinical comparability trial design is not feasible, other designs should be explored and their use discussed with the competent authorities Clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis

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PD CONSIDERATIONS

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