56
Views
3
CrossRef citations to date
0
Altmetric
Research Article

Bioequivalence Assessment of Generic Products: An Innovative South African Approach

, &
Pages 11-20 | Published online: 10 Oct 2008

REFERENCES

  • Meyer MC. Drug Product Selection. Part 2. Scientific Basis of Bioavailability and Bioequivalence Testing. Am Pharm. 1991; N531: 47–52
  • Molzon JA. The Generic Drug Approval Process. J Pharm Law 1996; 5: 275–284
  • Connor DP, Davit BM. Generic Drug Product Development: Solid Oral Dosage Forms, Shargel Leon, Kanfer Isadore. Marcel Dekker Inc. 2004
  • Schuirmann DJ. A comparison of the two one-sided test procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokin Biopharm. 1987; 15: 657–680, [CROSSREF]
  • Tothfalusi L, Endrenyi L, Midha KK. Scaling or wider bioequivalence limits for highly-variable drugs and for the special case of Cmax. Int J Clin Pharmacol Ther 2003; 41: 217–225, [PUBMED], [INFOTRIEVE]
  • Tothfalusi L, Endrenyi L. Limits for the scaled average bioequivalence of highly-variable drugs and drug products. Pharm Res 2003; 20(3)382–389, [PUBMED], [INFOTRIEVE], [CROSSREF]
  • http://www.fda.gov/cder/ob/default.htm, Approved Drug Products with Therapeutics Equivalence Evaluations, 21st Edition, Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Information Technology, Division of Data Management and Services (2001)

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.