Relative bioavailability of the fentanyl effervescent buccal tablet (FEBT) 1080 pg versus Oral transmucosal fentanyl citrate 1600 pg and dose proportionality of FEBT 270 to 1300 μg: A single-dose, randomized, open-label, three-period study in healthy adult volunteers
Consensus panel recommendations for the assessment and management of breakthrough pain: Part 2 management
Bennett D., Burton A.W., Fishman S., et al. Consensus panel recommendations for the assessment and management of breakthrough pain: Part 2 management. Pharm Ther 30 (2005) 354-361
Enhanced buccal delivery of fentanyl using the OraVescent drug delivery system
Pather S.I., Siebert J.M., Hontz J., et al. Enhanced buccal delivery of fentanyl using the OraVescent drug delivery system. Drug Deliv Tech 1 (2001) 54-57
The influence of in-vivo carbonation on GI physiological processes and drug permeability
Eichman J.D., Yassin A.E.-D.B., and Robinson J.R. The influence of in-vivo carbonation on GI physiological processes and drug permeability. Eurj Pharm Biopharm 44 (1997) 33-38
An open label study of oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough cancer pain
Fine P.G., Marcus M., De Boer A.J., and Van der Oord B. An open label study of oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough cancer pain. Pain 45 (1991) 149-153
Pharmacokinetics and dose proportionality of fentanyl effervescent buccal tablets in healthy volunteers
Darwish M., Tempero K., Kirby M., and Thompson J. Pharmacokinetics and dose proportionality of fentanyl effervescent buccal tablets in healthy volunteers. Clin Pharmacokinet 44 (2005) 1279-1286
[EMEA Web site]. ICH Topic E6. Accessed April 13, 2006, WHO, Geneva, Switzerland Accessed April 13, 2006
[EMEA Web site]. ICH Topic E6. European Agency for the Evaluation of Medicinal Products. Accessed April 13, 2006. International Conference on Harmonisation-World Health Organization. Guideline for Good Clinical Practice (2002), WHO, Geneva, Switzerland. http://www.emea.eu.int Accessed April 13, 2006
Available at:. US Dept of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. Accessed April 26 (2005). http://www.fda.gov/cder/guidance/3616fnl.pdf
Available at:. US Food and Drug Administration (FDA). Catalog of FDA Approved Drug Products: Actiq (NDA) #020747 Drug Details. Drug Details. Accessed February 9 (2006). http://www.accessdata.fda.gov/scripts/cder/dmgsatfda/index.cfm?fuseactio n=Search