Similarity Factor (F2) – false and illusionary “statistics”!

In case anyone is looking for sophisticated “statistical” jugglery, F2 provides an excellent example of thoroughly confusing people and science. Everyone must use it (compliance requirement), as suggested in the regulatory (FDA) guidance documents. This parameter has not been described in statistics and is irrelevant to assessing the quality of manufactured products (tablet/capsule). It has been developed using drug dissolution data and then applied to such data, which are invalid and irrelevant. Calculation-wise, it is simpler than calculating typical standard deviation, like a skill-test arithmetic exercise often provided at the back of lottery tickets or some promotion or advertisement (link).

Now consider this, a 2-day workshop/conference (yes, two full days) is organized at the university level to explain and teach about it to make it look like science or statistics!!! (link or here). There certainly is a disconnect between science and its practice at the regulatory level, which requires attention.

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