Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride.

@article{Becker2008BiowaiverMF,
  title={Biowaiver monographs for immediate release solid oral dosage forms: ethambutol dihydrochloride.},
  author={Corina Becker and Jennifer B. Dressman and Gordon L Amidon and Hans E. Junginger and Sabine Kopp and Kamal K. Midha and Vinod P. Shah and Salomon A. Stavchansky and Dirk M. Barends},
  journal={Journal of pharmaceutical sciences},
  year={2008},
  volume={97 4},
  pages={1350-60}
}
Literature 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 ethambutol dihydrochloride as the only active pharmaceutical ingredient (API) are reviewed. Ethambutol dihydrochloride is a Biopharmaceutics Classification System (BCS) Class III drug with permeability properties approaching the border between BCS Class I and III. BE problems of ethambutol formulations containing… CONTINUE READING
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