215
Views
23
CrossRef citations to date
0
Altmetric
Original Article

Evaluation of the bioequivalence of two transdermal fentanyl systems following single and repeat applications

, , , &
Pages 1961-1968 | Accepted 19 Sep 2005, Published online: 28 Oct 2005

References

  • Jeal W, Benfield P. Transdermal fentanyl. A review of its pharmacological properties and therapeutic efficacy in pain control. Drugs 53(1):109–38
  • Allan L, Hays H, Jensen NH, et al. Randomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer pain. Br Med J 2001;322(7295): 1154–8
  • Ahmedzai S, Brooks D. Transdermal fentanyl versus sustained-release oral morphine in cancer pain: preference, efficacy, and quality of life [The TTS­Fentanyl Comparative Trial Group]. J Pain Symptom Manage 1997;13(5):254–61
  • Clark AJ, Ahmedzai SH, Allan LG, et al. Efficacy and safety of transdermal fentanyl and sustained­release oral morphine in patients with cancer and chronic non­cancer pain. Curr Med Res Opin 2004;20(9):1419–28
  • Gidwani S, Sathyan G, Sun T, Gupta SK. Pharmacokinetic investigation of dose proportionality across a new D­TRANS® fentanyl matrix delivery system (D­TRANS® fentanyl) dose range. Poster presentation. 3rd World Congress of the World Institute of Pain, Barcelona, Spain, September, 2004. In: Devor M et al., editors. Pain practice. Blackwell Publishing; 2004. p. 288–9
  • Mehdizadeh A, Toliate T, Rouini MR, Abashzadeh S, Dorkoosh F. Design and in vitro evaluation of new drug­in­adhesive formulations of fentanyl transdermal patches. Acta Pharm 2004;54(4):301–17
  • Andresen C, Cochien MS, Sun T, Gupta SK, Sathyan G. Evaluation of the skin sensitization potential of components of a new D­TRANS® fentanyl matrix delivery system (D­TRANS® fentanyl), exclusive of fentanyl (Placebo D­TRANS®). Poster presentation, 24 September 2004. 3rd World Congress of the World Institute of Pain, Barcelona, Spain, September, 2004. In: Devor M, Erdine S, Ruiz­Lopez R, editors. Book of abstracts 3rd World Congress World Institute of Pain, September 21–25, 2004, Barcelona, Spain. Pain practice. p. 288–9
  • MLIC. Metropolitan height and weight tables. Stats Bull Met Life Insurance Company 1983;64:2–9
  • Anderson LS, Grafelman DD, Carnes EJ, Sartwell CJ, Andaloro VJ, Lin PP. Development and validation of an exceptionally sensitive LC–MS/MS method to analyze fentanyl and naltrexone in human serum. AAPS PharmSci 2002;4(4):[abstract W5207]
  • Portenoy RK, Southam MA, Gupta SK, et al. Transdermal fentanyl for cancer pain. Repeated dose pharmacokinetics. Anesthesiology 1993;78(1):36–43
  • Schuirmann DJ. A comparison of the two one­sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987;15(6):657–80
  • Chow S, Liu J. Statistical methods for average bioavailability. In: Design and analysis of bioavailability and bioequivalence studies. New York: Marcel Dekker; 1992. p. 70–125
  • FDA. Guidance for industry: statistical approaches to establishing bioequivalence. Rockville (MD): US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 2001
  • Gupta SK, Gidwani MS, Sun T, Sathyan G. Pharmacokinetic evaluation of a new D­TRANS® fentanyl matrix delivery system (D­TRANS® fentanyl) after single and repeated applications. Poster presentation, 24 September 2004. 3rd World Congress of the World Institute of Pain, Barcelona, Spain, September, 2004. In: Devor M, Erdine S, Ruiz­Lopez R, editors. Book of abstracts 3rd World Congress World Institute of Pain, September 21–25, 2004, Barcelona, Spain. Pain practice. p. 288–9
  • CPMP. Note for guidance on modified release oral and transdermal dosage forms: section II (pharmacokinetic and clinical evaluation). London: European Agency for the Evaluation of Medicinal Products, Committee for Proprietary Medicinal Products; 1999
  • Grond S, Radbruch L, Lehmann KA. Clinical pharmacokinetics of transdermal opioids: focus on transdermal fentanyl. Clin Pharmacokinet 2000;38(1):59–89
  • Sathyan G, Gidwani S, Sun T, Gupta SK. Evaluation of pharmacokinetic parameters in two skin types and age groups following a single application of a new D­TRANS® fentanyl matrix delivery system (D­TRANS® fentanyl). Poster presentation, 24 September 2004. 3rd World Congress of the World Institute of Pain, Barcelona, Spain, September, 2004. In: Devor M, Erdine S, Ruiz­Lopez R, editors. Book of abstracts 3rd World Congress World Institute of Pain, September 21–25, 2004, Barcelona, Spain. Pain practice. p. 288­9
  • Esteve M, Levron JC, Flaisler B, Schoefler P, Duvaldestin P, Chauvin M. Does aging modify pharmacokinetics of transdermal fentanyl? Anesthesiology 1991;75:A705

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.