Abstract
Principles of dissolution science have been applied to allow waiver of in vivo bioequivalence studies for oral immediate release solid dosage forms, providing certain stipulations are met. This approach reduces regulatory burden without sacrificing product quality and performance requirements that assure continuing equivalence. These principles are broadly applicable to other dosage forms and routes of administration. In this article, we postulate a further opportunity, which relies on a determination of “optimal performance” for nonsolution orally administered drug products. The determination can be applied to certain highly soluble and rapidly dissolving drug products without further study, paving the way possibly for even further reductions in regulatory burden.
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References
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Shah, V.P., Cecil, T.L., Srinivasan, S.V. et al. Progressively Reducing Regulatory Burden. AAPS J 16, 621–624 (2014). https://doi.org/10.1208/s12248-014-9601-z
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DOI: https://doi.org/10.1208/s12248-014-9601-z