BCS Class 3 Biowaivers and Transporter Considerations

Presentation – James E. Polli University of Maryland

  • Background
  • Prior human in vivo studies
  • Recent series of in vivo human studies of 14 common excipients
  • Potential transporter (or enzyme or nuclear receptor) x excipient interaction concern
  • Conclusions
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James E. Polli
[email protected]
October 27, 2015
355.pdf
Adobe Acrobat Document 1.7 MB

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