Bioequivalence and Bioequivalency Testing

  title={Bioequivalence and Bioequivalency Testing},
  author={Joseph P Balthasar},
PROLOGUE This lecture material is covered in one and one-half fiftyminute lecture periods. The primary objectives of the lecture are to: (i) review interpatient and intrapatient pharmacokinetic variability; (ii) introduce the concepts of therapeutic equivalence and bioequivalence; (iii) introduce the current FDA standards on bioequivalence; (iv) introduce the basic approach of bioequivalency testing; (v) provide an example of a clinical study assessing bioequivalence, showing calculations and… CONTINUE READING

From This Paper

Figures, tables, results, connections, and topics extracted from this paper.
9 Extracted Citations
11 Extracted References
Similar Papers

Citing Papers

Publications influenced by this paper.
Showing 1-9 of 9 extracted citations

Referenced Papers

Publications referenced by this paper.
Showing 1-10 of 11 references

ADAPT II User’s Guide: Pharmacokinetic / Pharmacodynamic Systems Analysis Software, Release 4, Biomedical Simulations

  • D. Z. D’Argenio, A. Schumitzky
  • 1997

bioequivalence. Food and Drug Administration Individual Bioequivalence Working Group,

  • R. N. Patnaik, L. J. Lesko, M. L. Chen, R. L. Williams
  • J. Pharmacokinet. Biopharm.,
  • 1996

Pharmacokinetics, 2nd ed

  • M. Gibaldi, D. Perrier
  • 1982

Similar Papers

Loading similar papers…