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Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development.
Tomlinson L, Ramsden D, Leite SB, Beken S, Bonzo JA, Brown P, Candarlioglu PL, Chan TS, Chen E, Choi CK, David R, Delrue N, Devine PJ, Ford K, Garcia MI, Gosset JR, Hewitt P, Homan K, Irrechukwu O, Kopec AK, Liras JL, Mandlekar S, Raczynski A, Sadrieh N, Sakatis MZ, Siegel J, Sung K, Sunyovszki I, Van Vleet TR, Ekert JE, Hardwick RN. Tomlinson L, et al. Among authors: ramsden d. Adv Biol (Weinh). 2023 Oct 9:e2300131. doi: 10.1002/adbi.202300131. Online ahead of print. Adv Biol (Weinh). 2023. PMID: 37814378
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.
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
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 Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidance from Regulatory Agencies: Guidelines on Model Fitting and Recommendations on Time Course for In Vitro Cytochrome P450 Induction Studies Including Impact on Drug Interaction Risk Assessment.
Wong SG, Ramsden D, Dallas S, Fung C, Einolf HJ, Palamanda J, Chen L, Goosen TC, Siu YA, Zhang G, Tweedie D, Hariparsad N, Jones B, Yates PD. Wong SG, et al. Among authors: ramsden d. Drug Metab Dispos. 2021 Jan;49(1):94-110. doi: 10.1124/dmd.120.000055. Epub 2020 Nov 2. Drug Metab Dispos. 2021. PMID: 33139460
358 results