2004P-0206
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FDA draft guidance, Bioavailability and Bioequivalence Studies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FDA, Statistical Information from the June 1999 Draft Guidance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FDA draft guidance, Bioavailability and Bioequivalence Studies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04/2003 FDA, Statistical Information from the June 1999 Draft
Guidance and the Statistical Information for In Vitro Bioequivalence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FDA draft guidance, Allergic Rhinitis: Clinical Development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