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Effectively Leveraging RWD for External Controls: A Systematic Literature Review of Regulatory and HTA Decisions.
Sola-Morales O, Curtis LH, Heidt J, Walsh L, Casso D, Oliveria S, Saunders-Hastings P, Song Y, Mercado T, Zusterzeel R, Mastey V, Harnett J, Quek RGW. Sola-Morales O, et al. Among authors: saunders hastings p. Clin Pharmacol Ther. 2023 Aug;114(2):325-355. doi: 10.1002/cpt.2914. Epub 2023 Jun 9. Clin Pharmacol Ther. 2023. PMID: 37079433 Review.
Regulatory and HTA Considerations for Development of Real-World Data Derived External Controls.
Curtis LH, Sola-Morales O, Heidt J, Saunders-Hastings P, Walsh L, Casso D, Oliveria S, Mercado T, Zusterzeel R, Sobel RE, Jalbert JJ, Mastey V, Harnett J, Quek RGW. Curtis LH, et al. Among authors: saunders hastings p. Clin Pharmacol Ther. 2023 Aug;114(2):303-315. doi: 10.1002/cpt.2913. Epub 2023 Jun 9. Clin Pharmacol Ther. 2023. PMID: 37078264 Review.
Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020.
Moll K, Lufkin B, Fingar KR, Ke Zhou C, Tworkoski E, Shi C, Hobbi S, Hu M, Sheng M, McCarty J, Shangguan S, Burrell T, Chillarige Y, Beers J, Saunders-Hastings P, Muthuri S, Edwards K, Black S, Kelman J, Reich C, Amend KL, Djibo DA, Beachler D, Ogilvie RP, Secora A, McMahill-Walraven CN, Seeger JD, Lloyd P, Thompson D, Dimova R, MaCurdy T, Obidi J, Anderson S, Forshee R, Wong HL, Shoaibi A. Moll K, et al. Among authors: saunders hastings p. Vaccine. 2023 Jan 9;41(2):333-353. doi: 10.1016/j.vaccine.2022.11.003. Epub 2022 Nov 8. Vaccine. 2023. PMID: 36404170 Free PMC article.
Development of an Evidence-Based Risk Assessment Framework.
Krewski D, Saunders-Hastings P, Baan RA, Barton-Maclaren TS, Browne P, Chiu WA, Gwinn M, Hartung T, Kraft AD, Lam J, Lewis RJ, Sanaa M, Morgan RL, Paoli G, Rhomberg L, Rooney A, Sand S, Schünemann HJ, Straif K, Thayer KA, Tsaioun K. Krewski D, et al. Among authors: saunders hastings p. ALTEX. 2022;39(4):667-693. doi: 10.14573/altex.2004041. Epub 2022 Sep 1. ALTEX. 2022. PMID: 36098377 Free PMC article.
Principles of risk decision-making.
Krewski D, Saunders-Hastings P, Larkin P, Westphal M, Tyshenko MG, Leiss W, Dusseault M, Jerrett M, Coyle D. Krewski D, et al. Among authors: saunders hastings p. J Toxicol Environ Health B Crit Rev. 2022 Jul 4;25(5):250-278. doi: 10.1080/10937404.2022.2107591. Epub 2022 Aug 18. J Toxicol Environ Health B Crit Rev. 2022. PMID: 35980104 Review.
The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing.
Deady M, Ezzeldin H, Cook K, Billings D, Pizarro J, Plotogea AA, Saunders-Hastings P, Belov A, Whitaker BI, Anderson SA. Deady M, et al. Among authors: saunders hastings p. Front Digit Health. 2021 Dec 22;3:777905. doi: 10.3389/fdgth.2021.777905. eCollection 2021. Front Digit Health. 2021. PMID: 35005697 Free PMC article.
Systematic review in evidence-based risk assessment.
Farhat N, Tsaioun K, Saunders-Hastings P, Morgan RL, Ramoju S, Hartung T, Krewski D. Farhat N, et al. Among authors: saunders hastings p. ALTEX. 2022;39(3):463–479. doi: 10.14573/altex.2004111. Epub 2021 Sep 27. ALTEX. 2022. PMID: 34585732 Free article.
16 results