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

@article{Jantratid2006BiowaiverMF,
  title={Biowaiver monographs for immediate release solid oral dosage forms: cimetidine.},
  author={Ekarat Jantratid and Sompol Prakongpan and Jennifer B. Dressman and Greg Amidon and Hans E. Junginger and Kamal K. Midha and Dirk M. Barends},
  journal={Journal of pharmaceutical sciences},
  year={2006},
  volume={95 5},
  pages={974-84}
}
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 cimetidine are reviewed. According to the current Biopharmaceutics Classification System (BCS), cimetidine would be assigned to Class III. Cimetidine's therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability (BA… CONTINUE READING

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