The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability which are the major characteristics of a drug substance that control its absorption in vivo ().
KEY WORDS: ANDA, BCS biowaiver, bioequivalence, Biopharmaceutics Classification System, generic drug product INTRODUCTION Antiallergic drugs in Class 1, drugs for pain relief in Class 2 and antidiabetic drugs in Class 3 have received the largest number of approvals during this period. The present data indicated a trend of more ANDA approvals of BCS Class 1 drugs than Class 3 or Class 2 drugs. Applying this list to evaluation of 263 ANDA approvals of BCS drugs during the period of 2000 to 2011 indicated 110 approvals (41.8%) for Class 1 drugs (based on both biowaiver and in vivo bioequivalence studies), 55 (20.9%) approvals for Class 2 drugs, 98 (37.3%) approvals for Class 3 drugs, and no (0%) approvals for Class 4 drugs. To categorize solubility and intestinal permeability properties of generic drugs under development, we used a list of 61 drugs which were classified as BCS 1, 2, 3, and 4 drugs with certainty in the World Health Organization Model List of Essential Medicines. The objective of this study was to use the World Health Organization Model List of Essential Medicines to determine the distribution of BCS Class 1, 2, 3, and 4 drugs in Abbreviated New drug Applications (ANDA) submissions. The Biopharmaceutics Classification system (BCS) classifies drug substances based on aqueous solubility and intestinal permeability. This article has been cited by other articles in PMC.
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