Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA
Journal Title: The AAPS Journal - Year 2012, Vol 14, Issue 1
Abstract
A generic product must meet the standards established by the Food and Drug Administration (FDA) to be approved for marketing in the USA. FDA approves a generic product for marketing if it is proved to be therapeutically equivalent to the reference product. Bioequivalence (BE) between a proposed generic product and its corresponding reference product is one of the major components of therapeutic equivalence. These approvals may be delayed if the BE portion of the submission is determined to be deficient. Many of these BE deficiencies recur commonly and can be avoided.
Authors and Affiliations
Qing Liu, Barbara M. Davit, Svetlana A. Cherstniakova, Suman Dandamudi, Johnetta F. Walters, Christina H. Lee, Kimberly W. Raines, Ke Ren, Leeh N. Williamson, Dale P. Conner
Keywords
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