Research Study

Why managing variability?

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This Research Study has been written by SIO/ADM , and any views and opinions expressed do not necessarily reflect those of

Why managing variability?

Significant efforts are necessary to develop an active pharmaceutical ingredient (API). It is therefore risky to expose this API to poorly characterized excipients with potential presence of many impurities (peroxides, aldehydes, organic acids, metals, residual solvents, etc.).

In many cases excipient is the key enabler of drug product performance and we have seen in the recent past several FDA recalls due to variability of excipients.

Natural based products are by definition subject to a certain degree of variability but appropriate solutions can be proposed by excipients suppliers.

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