1. FDA/CDER. Draft Guidance for Industry: Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action.Food and Drug Administration Web site. 1999. Available at: http://www.fda.gov/eder/guidance/2070DFT.pdf. Accessed: April 17, 2006.
2. Adams WP, Christopher D, Lee DS, et al. PQRI evaluation of cascade impactor profiles of pharmaceutical aerosols: Part 1—Background for a statistical method.AAPS Pharm Sci Tech. In press.
3. PQRI PSD Profile Comparisons Working Group. Work plan for the investigation of an optimized chi-square method for comparing particle size distribution profiles obtained by cascade impactors with specific reference to equivalence testing of orally inhaled and pressurized nasal drug products. 2002. Available at: http://www.pqri.org/commworking/ minutes/pdfs/dpte/psdpcwg/workplan02.pdf. Accessed: August 18, 2006.
4. Tsong Y. Statistical comparison of particle size distribution profiles. 2004. Available at: http://pqri.org/commworking/minutes/pdfs/dptc/ psdpcwg/Addl/DC01-475116-v2-Yi_Tsong_Statistical_Archive_PQRI_Profile_Comparisons. DOC. Accessed: April 20, 2006.
5. Lee D. Searching for the holy grail of a single PSD profile comparator. 2004. Available at: http://pqri.org/commworking/minutes/ pdfs/dptc/psdpcwg/Addl/DC01-504108-v1-Identical_Profiles_and_Stability_Slides. PPT. Accessed: April 20, 2006.