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
Related Articles
- EP ID EP681195
- DOI 10.1208/s12248-011-9312-7
- Views 56
- Downloads 0
External Validation of the Bilirubin–Atazanavir Nomogram for Assessment of Atazanavir Plasma Exposure in HIV-1-Infected Patients
Atazanavir increases plasma bilirubin levels in a concentration-dependent manner. Due to less costly and readily available assays, bilirubin has been proposed as a marker of atazanavir exposure. In this work, a previousl...
Emerging Technologies to Increase Ligand Binding Assay Sensitivity
Ligand binding assays (LBAs) have been the method of choice for protein analyte measurements for more than four decades. Over the years, LBA methods have improved in sensitivity and achieved larger dynamic ranges by usin...
Population analysis of the pharmacokinetics and pharmacodynamics of RWJ-270201 (BCX-1812) in treating experimental influenza A and B virus in healthy volunteers
Our objective was to assess the pharmacokinetics and pharmacodynamics of RWJ-270201 (BCX-1812), an oral neuraminidase inibitor for the treatment of influenza A and B virus in healthy volunteers.
Impact of Data Base Structure in a Successful In Vitro-In Vivo Correlation for Pharmaceutical Products
The in vitro-in vivo correlation (IVIVC) (Food and Drug Administration 1997) aims to predict performances in vivo of a pharmaceutical formulation based on its in vitro characteristics. It is a complex process that (i) in...
Gender-Dependent Pharmacokinetics of Veratramine in Rats: In Vivo and In Vitro Evidence
The online version of this article (doi:10.1208/s12248-016-9870-9) contains supplementary material, which is available to authorized users.