Gamalo M - Search Results

1

Extrapolation as a Default Strategy in Pediatric Drug Development.

Gamalo M, Bucci-Rechtweg C, Nelson RM, Vanh L, Porcalla A, Thackray H, Cooner F, Cutler L, Friend D, Portman R. Gamalo M, et al. Ther Innov Regul Sci. 2022 Nov;56(6):883-894. doi: 10.1007/s43441-021-00367-9. Epub 2022 Jan 10. Ther Innov Regul Sci. 2022. PMID: 35006587

2

Extent of safety database in pediatric drug development: types of assessment, analytical precision, and pathway for extrapolation through on-target effects.

Gamalo M, Zhao Y, Gao A, Ye J, Lin J, Eshida E, Choi Y, Nelson R. Gamalo M, et al. J Biopharm Stat. 2023 Nov 2;33(6):770-785. doi: 10.1080/10543406.2023.2172425. Epub 2023 Feb 26. J Biopharm Stat. 2023. PMID: 36843283

3

Platform trials to evaluate the benefit-risk of COVID-19 therapeutics: Successes, learnings, and recommendations for future pandemics.

Buenconsejo J, Liao R, Lin J, Singh P, Cooner F, Ghosh S, Gamalo M, Russek-Cohen E, Zariffa N. Buenconsejo J, et al. Among authors: gamalo m. Contemp Clin Trials. 2023 Sep;132:107292. doi: 10.1016/j.cct.2023.107292. Epub 2023 Jul 16. Contemp Clin Trials. 2023. PMID: 37454729

4

Pediatric Age Groups and Approach to Studies.

Job KM, Gamalo M, Ward RM. Job KM, et al. Among authors: gamalo m. Ther Innov Regul Sci. 2019 Sep;53(5):584-589. doi: 10.1177/2168479019856572. Epub 2019 Jul 16. Ther Innov Regul Sci. 2019. PMID: 31311309

5

A year in review: artificial intelligence permeates into mainstream statistics in pharmaceutical product development at a laggard pace.

Gamalo M. Gamalo M. J Biopharm Stat. 2021 Jan 2;31(1):1-4. doi: 10.1080/10543406.2021.1868425. J Biopharm Stat. 2021. PMID: 33739911 No abstract available.

6

Real-World Data as External Controls: Practical Experience from Notable Marketing Applications of New Therapies.

Izem R, Buenconsejo J, Davi R, Luan JJ, Tracy L, Gamalo M. Izem R, et al. Among authors: gamalo m. Ther Innov Regul Sci. 2022 Sep;56(5):704-716. doi: 10.1007/s43441-022-00413-0. Epub 2022 Jun 8. Ther Innov Regul Sci. 2022. PMID: 35676557 Review.

7

Analysis and reporting of pediatric growth and development assessment from clinical trials: overview and challenges.

Choi Y, Barbier N, Fürst-Recktenwald S, Ye J, Wajsbrot DB, Ishida E, Gamalo M. Choi Y, et al. Among authors: gamalo m. J Biopharm Stat. 2023 Nov 2;33(6):786-799. doi: 10.1080/10543406.2022.2154357. Epub 2022 Dec 21. J Biopharm Stat. 2023. PMID: 36541817

8

Composite Likelihoods with Bounded Weights in Extrapolation of Data.

Gamalo M, Kim Y, Zhang F, Lin J. Gamalo M, et al. J Biopharm Stat. 2023 Nov 2;33(6):708-725. doi: 10.1080/10543406.2022.2152835. Epub 2023 Jan 20. J Biopharm Stat. 2023. PMID: 36662162

9

Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.

Ye J, Zhang V, Strimenopoulou F, Zhao Y, Pan H, Shabbout M, Gamalo M. Ye J, et al. Among authors: gamalo m. J Biopharm Stat. 2023 Nov 2;33(6):681-695. doi: 10.1080/10543406.2023.2170407. Epub 2023 Feb 7. J Biopharm Stat. 2023. PMID: 36751009 Review.

10

Bigger and bigger circles - the expanding biopharmaceutical statistician's toolbox.

Gamalo M. Gamalo M. J Biopharm Stat. 2021 May 4;31(3):iii-xii. doi: 10.1080/10543406.2021.1932133. J Biopharm Stat. 2021. PMID: 34161190 No abstract available.

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