The Aerodynamic Particle Size Distribution Profile Comparisons WG is developing a robust statistical method (and evaluating that proposed in a draft FDA guidance) for establishing in vitro bioequivalence of aerosol particle size distributions of orally inhaled and intranasal drug products.
Draft Guidance for Industry-Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (1999, second draft 2003) http://www.fda.gov/cder/guidance/5383DFT.doc
Work Plan
Meeting Minutes
- January 12, 2007 (PDF)
- December 11, 2006 (PDF)
- September 18, 2006 (PDF)
- August 28, 2006 (PDF)
- July 31, 2006 (PDF)
- July 10, 2006 (PDF)
- June 15, 2006 (PDF)
- May 22, 2006 (PDF)
- April 12, 2006 (PDF)
- March 7, 2006 (PDF)
- January 9, 2006 (PDF)
- December 14, 2005 (PDF)
- December 1, 2005 (PDF)
- November 16, 2005 (PDF)
- October 19, 2005 (PDF)
- October 3, 2005 (PDF)
- July 13, 2005 (PDF)
- May 25, 2005 (PDF)
- May 11, 2005 (PDF)
- April 13, 2005 (PDF)
- March 23, 2005 (PDF)
- March 2, 2005 (PDF)
- February 16, 2005 (PDF)
- January 12, 2005 (PDF)
- December 15, 2004 (PDF)
- October 27, 2004 (PDF)
- September 22, 2004 (PDF)
- July 7, 2004 (PDF)
- June 23, 2004 (PDF)
- June 6, 2004 (PDF)
- May 26, 2004 (PDF)
- May 13, 2004 (PDF)
- April 27, 2004 (PDF)
- March 30, 2004 (PDF)
- March 15, 2004 (PDF)
- March 9, 2004 (PDF)
- March 3, 2004 (PDF)
- February 2, 2004 (PDF)
- January 13, 2004 (PDF)
- December 19, 2003 (PDF)
- August 5, 2003 (PDF)
- July 29, 2003 (PDF)
- June 26, 2003 (PDF)
- May 5, 2003 (PDF)
- April 2, 2003 (PDF)
- October 30, 2002 (PDF)
- October 24, 2002 (PDF)
- October 7, 2002 (PDF)
- September 16, 2002 (PDF)
- September 12, 2002 (PDF)
- August 30, 2002 (PDF)
- August 9, 2002 (PDF)
- July 18, 2002 (PDF)
- June 27, 2002 (PDF)
- June 4, 2002 (PDF)
- May 14, 2002 (PDF)
- April 17, 2002 (PDF)
- March 15, 2002 (PDF)
- January 28, 2002 (PDF)
- January 22, 2002 (PDF)
- December 6, 2001 (PDF)
- November 26, 2001 (PDF)
- November 16, 2001 (PDF)
Additional Materials of the Profile Comparison Working Group
- PBE Test Description (PDF)
- Systematic Study of 38 Scenarios (PDF)
- Realistic Scenarios 1-33 of 55 (PDF)
- Realistic Scenarios 34-55 of 55 (PDF)
- Statistical Comparison of Particle Size Distribution Profiles (DOC)
- Searching for the Holy Grail of a Single PSD Profile Comparator (PPT)
- Draft Simulation Results on Stability of the Chi-Square Ratio Statistic Under the Null Case of Identical Sets of Reference and Test Profiles (PPT)
- PQRI APSD Profile Comparisons Working Group’s Assessment (XLS)
- Thumbnail Plots and Scenario Descriptions (PDF)
PSD Profile Summary Discussion Comparison Subgroup