A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes
In vivo testing is a crucial part of product development. Most in vivo toxicology studies are conducted in a heavily regulated environment, in accordance with sound scientific principles, and in an ethical manner. Statistical methods are an important component of these scientific principles, and man...
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| Format: | Article |
| Language: | English |
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Sciendo
2025-01-01
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| Series: | Contributions to Tobacco and Nicotine Research |
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| Online Access: | https://doi.org/10.2478/cttr-2025-0003 |
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| author | Kondylis Athanasios Kogel Ulrike Ho Jenny Wong EeTsin Phillips Blaine Hoeng Julia Vanscheeuwijck Patrick |
| author_facet | Kondylis Athanasios Kogel Ulrike Ho Jenny Wong EeTsin Phillips Blaine Hoeng Julia Vanscheeuwijck Patrick |
| author_sort | Kondylis Athanasios |
| collection | DOAJ |
| description | In vivo testing is a crucial part of product development. Most in vivo toxicology studies are conducted in a heavily regulated environment, in accordance with sound scientific principles, and in an ethical manner. Statistical methods are an important component of these scientific principles, and many regulatory authorities provide guidelines or recommendations for statistical analyses and reporting. We propose a rigorous and comprehensive statistical approach to assess the impact of smoke exposure during in vivo comparative studies using statistical equivalence with variable equivalence limits based on historical data. The analysis enables comparison of the effect of a new/test aerosol to its reference/control while leveraging information about reference item variation across multiple studies. This approach is helpful in assessing the relevance of observed effects while incorporating sources of variability estimated using data from the current and previous experiments. The proposed method was used to analyze an OECD (Organization for Economic Co-operation and Development) 90-day inhalation study to determine the effects of exposure to smoke emitted by the new 1R6F reference cigarette as compared to the older 3R4F reference cigarette. Data from previous OECD 90-day in vivo studies using 3R4F cigarette smoke were used to improve our assessment of the effects observed in the current study. |
| format | Article |
| id | doaj-art-3b5ae7e55ebd4f7ab4c04006da91822c |
| institution | Kabale University |
| issn | 2719-9509 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Contributions to Tobacco and Nicotine Research |
| spelling | doaj-art-3b5ae7e55ebd4f7ab4c04006da91822c2025-02-02T15:47:56ZengSciendoContributions to Tobacco and Nicotine Research2719-95092025-01-01341263310.2478/cttr-2025-0003A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference CigarettesKondylis Athanasios0Kogel Ulrike1Ho Jenny2Wong EeTsin3Phillips Blaine4Hoeng Julia5Vanscheeuwijck Patrick6PMI R&D, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000Neuchâtel, SwitzerlandPMI R&D, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000Neuchâtel, SwitzerlandVectura Fertin Pharma Laboratories Pte. Ltd., Science Park II, SingaporeVectura Fertin Pharma Laboratories Pte. Ltd., Science Park II, SingaporeVectura Fertin Pharma Laboratories Pte. Ltd., Science Park II, SingaporePMI R&D, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000Neuchâtel, SwitzerlandPMI R&D, Philip Morris Products S.A., Quai Jeanrenaud 5, 2000Neuchâtel, SwitzerlandIn vivo testing is a crucial part of product development. Most in vivo toxicology studies are conducted in a heavily regulated environment, in accordance with sound scientific principles, and in an ethical manner. Statistical methods are an important component of these scientific principles, and many regulatory authorities provide guidelines or recommendations for statistical analyses and reporting. We propose a rigorous and comprehensive statistical approach to assess the impact of smoke exposure during in vivo comparative studies using statistical equivalence with variable equivalence limits based on historical data. The analysis enables comparison of the effect of a new/test aerosol to its reference/control while leveraging information about reference item variation across multiple studies. This approach is helpful in assessing the relevance of observed effects while incorporating sources of variability estimated using data from the current and previous experiments. The proposed method was used to analyze an OECD (Organization for Economic Co-operation and Development) 90-day inhalation study to determine the effects of exposure to smoke emitted by the new 1R6F reference cigarette as compared to the older 3R4F reference cigarette. Data from previous OECD 90-day in vivo studies using 3R4F cigarette smoke were used to improve our assessment of the effects observed in the current study.https://doi.org/10.2478/cttr-2025-0003in vivo testingreference cigarette smokestatistical equivalencestatistical intervals |
| spellingShingle | Kondylis Athanasios Kogel Ulrike Ho Jenny Wong EeTsin Phillips Blaine Hoeng Julia Vanscheeuwijck Patrick A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes Contributions to Tobacco and Nicotine Research in vivo testing reference cigarette smoke statistical equivalence statistical intervals |
| title | A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes |
| title_full | A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes |
| title_fullStr | A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes |
| title_full_unstemmed | A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes |
| title_short | A Statistical Approach for Comparative Assessment of the Effect of Smoke Exposure in In Vivo Experiments: A Case Study of an OECD 90-Day Inhalation Study Including 3R4F and 1R6F Reference Cigarettes |
| title_sort | statistical approach for comparative assessment of the effect of smoke exposure in in vivo experiments a case study of an oecd 90 day inhalation study including 3r4f and 1r6f reference cigarettes |
| topic | in vivo testing reference cigarette smoke statistical equivalence statistical intervals |
| url | https://doi.org/10.2478/cttr-2025-0003 |
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