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A drug product is eligible for a BCS-based biowaiver provid that the drug substance(s) satisfy the ed criteria regarding solubility and permeability (BCS Class I and III), the drug product is an immediate-release oral dosage form with systemic action, and the drug product is dosage the same form and strength as the reference product. We evaluated 263 approved generic drugs of IR products listed on the WHO EML to find out the distribution of BCS Class 1, 2, 3, and 4 drugs in approved ANDA applications during the 2000 to 2011 period. The WHO EML was used as it is a publicly available list of Class 1, 2, 3, and 4 drugs. The drug has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug may lead to severe psychological or physical dependence. The following drugs are listed as Schedule 2 (II) Drugs. by the Controlled Substances Act (CSA). Unfavorable class (i.e., from high to low solubility). Observed changes point out potential di erences in product performance in pediatrics compared to adults, due to changes in the limiting factors for absorption. BCS Class Changes 1 to 2 or 3 to 4 are indicative of drugs that could be more.

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Bcs Class Ii

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