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Draft Guidance for Industry-Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (1999, second draft 2003)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

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 (PDF)

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

• March 9, 2004
• February 10-25, 2004