2004P-0239
REF 1
Volume 3

List of References

06/1999 FDA draft guidance, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

04/2003 FDA, Statistical Information from the June 1999 Draft Guidance and the Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999

04/2003 FDA draft guidance, Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action

04/2003 FDA, Statistical Information from the June 1999 Draft Guidance and the Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999

07/2002 FDA guidance, Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentation

07/2002 FDA guidance, Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products - Chemistry, Manufacturing, and Controls Documentation

06/1995 FDA guidance, Topical Dermatologic Corticosteroids: In Vivo Bioequivalence

11/02/2001 Cheng, Y.S., et al., "Characterization of Nasal Spray Pumps and Deposition Pattern in a Replica of the Human Nasal Airway," Journal of Aerosol Medicine, 14 (2):267-80, 2001 Published Material

Dighe, S.V., and W.P. Adams, "Bioequivalence: A United States Regulatory Perspective," in Pharmaceutical Bioequivalence (P.G . Welling et al., eds.), 1991, pp. 347-380 Published Material

04/28/2004 Daley-Yates et al., "Bioavailability of Fluticasone Propionate and Mometasone Furoate Aqueous Nasal Sprays," European Journal of Clinical Pharmacology, 60 (4): 265-268, 2004 Published Material

2006 USP Monographs: Fluticasone Propionate Published Material

04/2000 FDA draft guidance, Allergic Rhinitis: Clinical Development Programs for Drug Products