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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
Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance.
Kenny JR, Ramsden D, Buckley DB, Dallas S, Fung C, Mohutsky M, Einolf HJ, Chen L, Dekeyser JG, Fitzgerald M, Goosen TC, Siu YA, Walsky RL, Zhang G, Tweedie D, Hariparsad N. Kenny JR, et al. Among authors: ramsden d. Drug Metab Dispos. 2018 Sep;46(9):1285-1303. doi: 10.1124/dmd.118.081927. Epub 2018 Jun 29. Drug Metab Dispos. 2018. PMID: 29959133
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
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
359 results