Module 9 2021

19/03/2021

Analytical Characterisation • Quality testing should include but not be limited to product specifications and tests that are the most sensitive to the proposed change. • Potency assays may reflect only one aspect of the molecules activity • Trend analysis or comparison to historical ranges may suggest a product change • Stress testing can also provide valuable information

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Hierarchical Comparability Assessment Ultimately Clinical Consequence QUESTIONS Has the change impacted

Analytical Characterization Identify the Quality Attributes of the Product

product quality ? Is the process still capable of meeting defined requirements?

Biological Characterization Assess the Affect of Product Attributes on Potency

Are there detectable differences in preclinical models?

Preclinical Assessment Assess PK, Bioavailability, Toxicology, PD

What is the impact to patients?

Clinical Assessment Investigate PK, Bioavailability, Safety, Efficacy,

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