Biowaiver monographs for immediate release solid oral dosage forms: furosemide.

  title={Biowaiver monographs for immediate release solid oral dosage forms: furosemide.},
  author={Gladys Ester Granero and Marcela Raquel Longhi and Mar{\'i}a Julia Mora and Hans E. Junginger and Kamal K. Midha and Vinod P. Shah and Salomon A. Stavchansky and Jennifer B. Dressman and Dirk M. Barends},
  journal={Journal of pharmaceutical sciences},
  volume={99 6},
Literature and new experimental data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing furosemide are reviewed. The available data on solubility, oral absorption, and permeability are sufficiently conclusive to classify furosemide into Class IV of the Biopharmaceutics Classification System (BCS). Furosemide's therapeutic use and therapeutic index, its pharmacokinetic properties, data… CONTINUE READING
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Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System

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