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Presented at the Advisory Committee for Pharmaceutical Science meeting on March 13, 2003 by Yi Tsong

Presented at the Advisory Committee for Pharmaceutical Science meeting on March 13, 2003 by Yi Tsong . Operating Characteristic Curve. Producer protection region ( changes with sample size ). 100. 90. 80. Area of uncertainty. 70. 60. Probability to Accept (%).

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Presented at the Advisory Committee for Pharmaceutical Science meeting on March 13, 2003 by Yi Tsong

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  1. Presented at the Advisory Committee for Pharmaceutical Science meeting on March 13, 2003 by Yi Tsong

  2. Operating Characteristic Curve Producer protection region (changes with sample size) 100 90 80 Area of uncertainty 70 60 Probability to Accept (%) Quality Assurance Region (fixed) 50 40 30 20 10 5% 0 Consumer protection region Variability (either standard deviation at a given batch mean or coverage)

  3. Comparison of Operating Characteristic Curves 21 “Gap” QA Region LQ FDA test: as in Draft MDI/DPI Guidance • Lower Consumer protection (QA Region) • PTI test’s curve is sharper (narrowed area of uncertainty) • More uncertainly quality batches accepted (lower product quality) • “Gap”: Fewer rejections does mean lower quality of accepted batches

  4. 22 Examples of Effect of Deviations on current FDA OC Curve FDA DCU & TCL test as in Draft MDI/DPI Guidance • Majority of OINDP products approved by FDA in 1990-2001 have DDU test or acceptance criteria or both that deviate from draft Guidances (IPAC-RS 2001 survey) • The ”gap” between FDA and PTI OC curves decreases with such deviations, and consumer protection is eroded • PTIT provides reduction of producer risk without compromising consumer protection

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