Altria Group, Inc. · NYSE:MO
Altria — Technical Presentation (September 2023)
17 slides from Altria's technical presentation, Sep 24, 2023
Slide 1: Horwitz-Thompson Equation as a Benchmark for CORESTA Collaborative Study Results
Horwitz-Thompson Equation as a Benchmark for CORESTA Collaborative Study Results Michael J. Morton Michael.J.Morton@altria.com Altria Client Services LLC Center for Research and Technology Richmond, VA 23219 Altria Client Services | 76th Tobacco Sciences Research Conference | September 24-27, 2023 1
Slide 2: Collaborative Study Results and Method Standardization
Collaborative Study Results and Method Standardization BASED ON THE RESULTS Analytical Method Standardization HT equation is a typically requires a collaborative study with multiple reasonable benchmark labs conducting the method on matched samples to for tobacco and tobacco determine if the analyti
Slide 3: Horwitz Equation
Horwitz Equation William Horwitz Michael Thompson and Colleagues at FDA Examined collaborative study data and developed an proposed alternative set of equations equation to describe analytical variation as a function as a remedy of the concentration of the analyte 𝝈𝝈𝑹𝑹 = 𝟎𝟎. 𝟎𝟎𝟎𝟎 𝑪𝑪…
Slide 4: Original Horwitz Equation vs. Horwitz-Thompson Equation
Original Horwitz Equation vs. Horwitz-Thompson Equation Original Horwitz Horwitz-Thompson %Reproducibility SD 𝜎𝜎𝑅𝑅 = 0.02𝐶𝐶 0.85 , 𝜎𝜎𝑅𝑅 ⁄𝐶𝐶 = 0.02𝐶𝐶 −0.15 𝑛𝑛𝑛𝑛 120 ≤ 𝐶𝐶 < 13.8% 𝜎𝜎𝑅𝑅 = 0.22𝐶𝐶 , 𝑔𝑔 𝜎𝜎𝑅𝑅 = 0.01 𝐶𝐶, 𝜎𝜎𝑅𝑅 𝜎𝜎𝑅𝑅 ⁄𝐶𝐶 = 0.01𝐶𝐶 −0.5 �𝐶𝐶 = 0.22…
Slide 5: Uncertainty in Estimated Reproducibility Estimates
Uncertainty in Estimated Reproducibility Estimates Variability is challenging to estimate accurately – even under ideal conditions FOR EXAMPLE: In a (Simulated) collaborative study with: • 10 labs and 3 reps per lab • 95% confidence interval for the estimated reproducibility standard deviation (unde
Slide 6: Tobacco and Smokeless Tobacco Chemical Analysis Analytes
Tobacco and Smokeless Tobacco Chemical Analysis Analytes Products included in this evaluation: Smokeless tobacco products | Cigarette and cigar filler | Leaf tobacco CLASS ANALYTE(S) DATA SOURCE Ammonia Ammonia CRM 79 BaP BaP CRM 82 Carbonyls Acetaldehyde, Formaldehyde CRM 86 Arsenic, Beryllium, Cad
Slide 7: Tobacco and Smokeless Tobacco Product Analyte Reproducibility StdDevs
Tobacco and Smokeless Tobacco Product Analyte Reproducibility StdDevs Horwitz-Thompson Original Horwitz Ammonia BaP Carbonyls Metals TSNAs Moisture PAHs Nicotine Percent StdDev Concentration (Amount per gram) Altria Client Services | 76th Tobacco Sciences Research Conference | September 24-27, 2023
Slide 8: Tobacco Analyte Reproducibility StdDevs vs. Horwitz-Thompson Predicted Values
Tobacco and Smokeless Tobacco Product Analyte Reproducibility StdDevs vs. Horwitz-Thompson Predicted Values In(sR/pred sR) Some analytes are consistently above the HT predicted values. This could be a consequence of the analyte being intrinsically more difficult or the method needing additional work
Slide 9: Summary of Tobacco and Smokeless Tobacco Product Comparison to Horwitz-Thompson Equation
Summary of Tobacco and Smokeless Tobacco Product Comparison to Horwitz-Thompson Equation OVERALL, ON AVERAGE Values compared reasonably well to the HT equation The natural log ratio to the equation showed the CORESTA values averaged about 2.6% higher than the HT equation Some analytes, known to be d
Slide 10: Application to Cigarette Smoke Analyte Yields
Application to Cigarette Smoke Analyte Yields A Proposed HT EQUATION Approach does not directly apply to smoke yields approximate weight of cigarette as ~1 gram because they are an amount, not a mass/mass concentration think of yield as weight per 1 gram cigarette* * Equivalence Testing for SE Evalu
Slide 11: Cigarette Smoke Analytes
Cigarette Smoke Analytes CLASS ANALYTE(S) DATA SOURCE Ammonia Ammonia CRM 74 1-Aminonaphthalene, 2-Aminonaphthalene, 2,6-Dimethylaniline, Aromatic Amines CRM 95 o-Anisidine, o-Toluidine, 3-Aminobiphenyl, 4-Aminobiphenyl B(a)P B(a)P CRM 58 2-Butonone, Acetaldehyde, Acetone, Acrolein, Crotonaldehyde,
Slide 12: Cigarette Smoke Yield Analyte Reproducibility Standard Deviations
Cigarette Smoke Yield Analyte Reproducibility Standard Deviations Horwitz-Thompson Original Horwitz Ammonia B(a)P Carbonyls TNCO TSNA VOC AA Percent StdDev Concentration (Yield per cigarette) Altria Client Services | 76th Tobacco Sciences Research Conference | September 24-27, 2023 12
Slide 13: Cigarette Smoke Yield Reproducibility vs. Horwitz-Thompson Predicted Values
Cigarette Smoke Yield Analyte Reproducibility Standard Deviations vs. Horwitz-Thompson Predicted Values Most analytes are above the HT predicted values In(sR/pred sR) BaP and the TSNAs tend to be below the predicted values CO stands out among the TNCO analytes as being above the predicted values Ana
Slide 14: Summary of Cigarette Smoke Yield Comparison to the Horwitz-Thompson Equation
Summary of Cigarette Smoke Yield Comparison to the Horwitz-Thompson Equation Comparison to the HT LIKELY POSSIBLE equation was different Additional variability Yield variability for different analytes induced by smoking could be different • TNCO (excepting CO), B[a]P, CONTRIBUTES to for different ci
Slide 15: Overall Summary
Overall Summary Tobacco and smokeless tobacco Cigarette smoke analytes were generally in line analytes were with the HT predicted values generally above HT equation can reasonably serve the HT predicted as a performance benchmark values with a few exceptions for these analytical methods Recommend Ca
Slide 16: References
References • William Horwitz, Laverne R. Kamps, and Kenneth W. Boyer, “Quality Assurance in the Analysis of Foods for Trace Constituents,” J. Assoc. Off. Anal. Chem. (Vol 63, No 6, 1980), pp 1344-1354. • William Horwitz, “Evaluation of Analytical Methods Used for Regulation of Foods and Drugs,” Anal
Slide 17: Acknowledgment
Acknowledgment My thanks to Karl Wagner who suggested this topic Altria Client Services | 76th Tobacco Sciences Research Conference | September 24-27, 2023 17
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