Bioequivalence for Topical Products—An Update

@article{Narkar2010BioequivalenceFT,
  title={Bioequivalence for Topical Products—An Update},
  author={Yogeeta Narkar},
  journal={Pharmaceutical Research},
  year={2010},
  volume={27},
  pages={2590-2601}
}
With the exception of topical glucocorticoids, demonstrating bioequivalence between generic and reference topical products entails conducting clinical end-point trials which are both lengthy and expensive. Considerable effort has been channeled towards development and validation of alternative approaches to demonstrate bioequivalence of topical and transdermal products. The critical opportunity pathways identified by the FDA for the industry for topical bioequivalence include the following… CONTINUE READING

Citations

Publications citing this paper.
Showing 1-10 of 12 extracted citations

References

Publications referenced by this paper.
Showing 1-10 of 107 references

for Industry

  • US FDA. Guidanc
  • Nonsterile semisolid dosage forms, scale-up and…
  • 1997
Highly Influential
4 Excerpts

Bioequivalence assessment of three 0.025% tretinoin gel products: dermatopharmacokinetic vs. clinical trial methods

  • LK Pershing
  • 2010

Differences in DPK methods. http://www.fda.gov/ ohrms/dockets/ac/01/slides/3804s2_05_conner//index.htm (accessed 6/25/2010)

  • DP Conner
  • 2010

Similar Papers

Loading similar papers…