Module 9 2024

03/09/2024

Comparability considerations

Forced degradation Data

Stability Data

Characterisation Data

Nonclinical bridging

Clinical bridging

Development stage Batch Data

Preclinical

X

Phase 1

X

X

X*

Phase 2/3

X

X

X

X**

X*

X*

Pre Filing

X

X

X

X**

X*

X*

Post approval

X

X

X

X**

X*

X*

It is noted this is just an example, the actual studies are defined based on a case by case basis

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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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16