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Comparability Study

Meaning

A Comparability Study is a comprehensive scientific and regulatory exercise conducted by pharmaceutical and biotechnology companies to demonstrate that a product’s quality, safety, and efficacy remain highly similar after a significant change in its manufacturing process. This is particularly critical for complex biologic drugs, including hormone-based therapies and growth factors, where the manufacturing process essentially defines the product itself. The study’s conclusion assures regulators that the pre-change clinical data remains applicable to the post-change product.