The Food and Drug Administration (FDA) is reopening the comment period related to the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE) of nonsystemically absorbed drug products intended for use in veterinary species, published in the Federal Register of March 18, 2015 (80 FR 14146). FDA is reopening the comment period to receive new information.
Document
Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening the comment period related to the use of in vitro methods as a mechanism for assessing the in vivo product bioequivalence (BE...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 59787
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals; Reopening of the Comment Period,” thefederalregister.org (October 2, 2015), https://thefederalregister.org/documents/2015-25121/identification-of-alternative-in-vitro-bioequivalence-pathways-which-can-reliably-ensure-in-vivo-bioequivalence-of-produ.