Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration

“For-cause” inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and study irregularities are discovered. We investigated the common reasons for initiating “for-cause” inspections related to the cli...

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Autors principals: Li, Bing V., Davit, Barbara M., Lee, Christina H., Pabba, Santhosh K., Mahadevan, Chitra, Caramenico, Hoainhon T., Haidar, Sam H, Sanchez, Aida L., Sigler, Aaron W., Stier, Ethan M., Conner, Dale P.
Format: Artigo
Idioma:Inglês
Publicat: Springer US 2012
Matèries:
Regulatory Note
Accés en línia:https://ncbi.nlm.nih.gov/pmc/articles/PMC3535114/
https://ncbi.nlm.nih.gov/pubmed/23054974
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-012-9415-9
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