Biowaiver For Pseudoephedrine

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MPCP Says:


Pseudoephedrine is a BCS class 3 compound. What is needed to get a biowaiver for an EU country (FDA has a more stricter view on BCS class 3)? Would dissolution data work? I can't imagine conducting a BE study for an OTC drug, but can't find justification to waive one. Thank you!



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David Says:

Although I'm not totally familiar with this topic, I did come across a brief article of information that I thought could be of assistance. Unfortunately it's not European-based, but I hope it helps shed some light on the FDA's level of strictness:

"Biopharmaceutics Classification System (BCS) is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence studies, also called a biowaiver. According to the 2000 FDA BCS Guidance, compounds that are classified as Class I (highly soluble, highly permeable) are eligible for BCS biowaivers. For such compounds, the rate and extent of drug absorption is unlikely to be affected by drug dissolution and/or GI residence time, and in vivo bioequivalence studies (for new formulations, etc.) may be waived based on in vitro permeability and solubility data."

BCS divides compounds into four categories:
• Class I - High Solubility, High Permeability
• Class II - Low Solubility, High Permeability
• Class III - High Solubility, Low Permeability
• Class IV - Low Solubility, Low Permeability

Does anyone know if EU countries have different regulations in place?

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