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Perspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate).
Baran SW, Brown PC, Baudy AR, Fitzpatrick SC, Frantz C, Fullerton A, Gan J, Hardwick RN, Hillgren KM, Kopec AK, Liras JL, Mendrick DL, Nagao R, Proctor WR, Ramsden D, Ribeiro AJS, Stresser D, Sung KE, Sura R, Tetsuka K, Tomlinson L, Van Vleet T, Wagoner MP, Wang Q, Arslan SY, Yoder G, Ekert JE. Baran SW, et al. Among authors: ramsden d. ALTEX. 2022;39(2):297–314. doi: 10.14573/altex.2112203. Epub 2022 Jan 21. ALTEX. 2022. PMID: 35064273 Free article.
The Nonclinical Disposition and Pharmacokinetic/Pharmacodynamic Properties of N-Acetylgalactosamine-Conjugated Small Interfering RNA Are Highly Predictable and Build Confidence in Translation to Human.
McDougall R, Ramsden D, Agarwal S, Agarwal S, Aluri K, Arciprete M, Brown C, Castellanos-Rizaldos E, Charisse K, Chong S, Cichocki J, Fitzgerald K, Goel V, Gu Y, Guenther D, Habtemariam B, Jadhav V, Janas M, Jayaraman M, Kurz J, Li J, Liu J, Liu X, Liou S, Maclauchlin C, Maier M, Manoharan M, Nair JK, Robbie G, Schmidt K, Smith P, Theile C, Vaishnaw A, Waldron S, Xu Y, Zhang X, Zlatev I, Wu JT. McDougall R, et al. Among authors: ramsden d. Drug Metab Dispos. 2022 Jun;50(6):781-797. doi: 10.1124/dmd.121.000428. Epub 2021 Jun 21. Drug Metab Dispos. 2022. PMID: 34154993 Review.
Current Practices, Gap Analysis, and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective.
Hariparsad N, Ramsden D, Taskar K, Badée J, Venkatakrishnan K, Reddy MB, Cabalu T, Mukherjee D, Rehmel J, Bolleddula J, Emami Riedmaier A, Prakash C, Chanteux H, Mao J, Umehara K, Shah K, De Zwart L, Dowty M, Kotsuma M, Li M, Pilla Reddy V, McGinnity DF, Parrott N. Hariparsad N, et al. Among authors: ramsden d. Clin Pharmacol Ther. 2022 Oct;112(4):770-781. doi: 10.1002/cpt.2503. Epub 2021 Dec 24. Clin Pharmacol Ther. 2022. PMID: 34862964
Considerations from the IQ Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control.
Hariparsad N, Ramsden D, Palamanda J, Dekeyser JG, Fahmi OA, Kenny JR, Einolf H, Mohutsky M, Pardon M, Siu YA, Chen L, Sinz M, Jones B, Walsky R, Dallas S, Balani SK, Zhang G, Buckley D, Tweedie D. Hariparsad N, et al. Among authors: ramsden d. Drug Metab Dispos. 2017 Oct;45(10):1049-1059. doi: 10.1124/dmd.116.074567. Epub 2017 Jun 23. Drug Metab Dispos. 2017. PMID: 28646080
367 results