comparable
- Guideline or reference source
- ICHQ5E comparability of biotechnological/biological products
- Definition
- A conclusion that products have highly similar quality attributes before and after manufacturing process changes and that no adverse impact on the safety or efficacy, including immunogenicity, of the drug product occurred. This conclusion can be based on an analysis of product quality attributes. In some cases, nonclinical or clinical data might contribute to the conclusion.
- Related Term
- comparability bridging study
- comparator product
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