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Asia-inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler.
Lu H, Klopp-Schulze L, Mukker JK, Li D, Kuroki Y, Bolleddula J, Terranova N, Goteti K, Gao W, Strotmann R, Dong J, Venkatakrishnan K. Lu H, et al. Among authors: bolleddula j. Clin Transl Sci. 2024 Oct;17(10):e70050. doi: 10.1111/cts.70050. Clin Transl Sci. 2024. PMID: 39445632 Free PMC article. Review.
Establishing a physiologically based pharmacokinetic framework for aldehyde oxidase and dual aldehyde oxidase-CYP substrates.
Izat N, Bolleddula J, Carione P, Huertas Valentin L, Jones RS, Kulkarni P, Moss D, Peterkin VC, Tian DD, Treyer A, Venkatakrishnan K, Zientek MA, Barber J, Houston JB, Galetin A, Scotcher D. Izat N, et al. Among authors: bolleddula j. CPT Pharmacometrics Syst Pharmacol. 2025 Jan;14(1):164-178. doi: 10.1002/psp4.13255. Epub 2024 Oct 23. CPT Pharmacometrics Syst Pharmacol. 2025. PMID: 39444174 Free PMC article.
Building Confidence in Physiologically Based Pharmacokinetic Modeling of CYP3A Induction Mediated by Rifampin: An Industry Perspective.
Reddy MB, Cabalu TD, de Zwart L, Ramsden D, Dowty ME, Taskar KS, Badée J, Bolleddula J, Boulu L, Fu Q, Kotsuma M, Leblanc AF, Lewis G, Liang G, Parrott N, Pilla Reddy V, Prakash C, Shah K, Umehara K, Mukherjee D, Rehmel J, Hariparsad N. Reddy MB, et al. Among authors: bolleddula j. Clin Pharmacol Ther. 2024 Oct 18. doi: 10.1002/cpt.3477. Online ahead of print. Clin Pharmacol Ther. 2024. PMID: 39422118 Review.
A phase I study of ATR inhibitor gartisertib (M4344) as a single agent and in combination with carboplatin in patients with advanced solid tumours.
Burris HA, Berlin J, Arkenau T, Cote GM, Lolkema MP, Ferrer-Playan J, Kalapur A, Bolleddula J, Locatelli G, Goddemeier T, Gounaris I, de Bono J. Burris HA, et al. Among authors: bolleddula j. Br J Cancer. 2024 Apr;130(7):1131-1140. doi: 10.1038/s41416-023-02436-2. Epub 2024 Jan 29. Br J Cancer. 2024. PMID: 38287179 Free PMC article. Clinical Trial.
Challenges and Opportunities for In Vitro-In Vivo Extrapolation of Aldehyde Oxidase-Mediated Clearance: Toward a Roadmap for Quantitative Translation.
Izat N, Bolleddula J, Abbasi A, Cheruzel L, Jones RS, Moss D, Ortega-Muro F, Parmentier Y, Peterkin VC, Tian DD, Venkatakrishnan K, Zientek MA, Barber J, Houston JB, Galetin A, Scotcher D. Izat N, et al. Among authors: bolleddula j. Drug Metab Dispos. 2023 Dec;51(12):1591-1606. doi: 10.1124/dmd.123.001436. Epub 2023 Sep 26. Drug Metab Dispos. 2023. PMID: 37751998
25 results