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The following message was posted to: PharmPK
Could anybody please advice me on the Bioequivalence (BE) requirements
for
Cefadroxil Tablets, for US FDA submission.
To be more specific, whether BE studies in fed condition (in addition to
fasted study) would be required or only fasted study suffices the
regulatory
requirements.
All comments are welcome.
Kind regards,
Hitesh Maheshwari
Hikma Pharmaceuticals
Amman-Jordan
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