Common Deficiencies with Bioequivalence Submissions in Abbreviated New Drug Applications Assessed by FDA

PURPOSE: 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 prop...

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Detalhes bibliográficos
Main Authors: Liu, Qing, Davit, Barbara M., Cherstniakova, Svetlana A., Dandamudi, Suman, Walters, Johnetta F., Lee, Christina H., Raines, Kimberly W., Ren, Ke, Williamson, Leeh N., Conner, Dale P.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer US 2011
Assuntos:
Regulatory Note
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3291193/
https://ncbi.nlm.nih.gov/pubmed/22130775
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-011-9312-7
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