Dissolution specifications based on release rates.

  • Zeev Elkoshi
  • Published 1999 in Journal of pharmaceutical sciences


A procedure based on release rates is proposed for the establishment of dissolution specifications that ensure the bioequivalence of a test and a reference product. This procedure, which confines Cmax (the maximum concentration of the drug in vivo) and AUCinfinity (the area under the time-concentration curve, extrapolated to infinity) values within any… (More)


Cite this paper

@article{Elkoshi1999DissolutionSB, title={Dissolution specifications based on release rates.}, author={Zeev Elkoshi}, journal={Journal of pharmaceutical sciences}, year={1999}, volume={88 4}, pages={434-44} }