REFERENCES
Gertz MA, & Dispenzieri A (2020). Systemic Amyloidosis Recognition, Prognosis, and Therapy: A Systematic Review. JAMA 324: 79-89.
Gomez-Mantilla JD, Huang F, & Peters SA (2023). Can Mechanistic Static Models for Drug-Drug Interactions Support Regulatory Filing for Study Waivers and Label Recommendations? Clin Pharmacokinet 62: 457-480.
Klammers F, Goetschi A, Ekiciler A, Walter I, Parrott N, Fowler S, et al. (2022). Estimation of Fraction Metabolized by Cytochrome P450 Enzymes Using Long-Term Cocultured Human Hepatocytes. Drug Metab Dispos 50: 566-575.
Lin W, Chen Y, Unadkat JD, Zhang X, Wu D, & Heimbach T (2022). Applications, Challenges, and Outlook for PBPK Modeling and Simulation: A Regulatory, Industrial and Academic Perspective. Pharm Res 39: 1701-1731.
Lindmark B, Lundahl A, Kanebratt KP, Andersson TB, & Isin EM (2018). Human hepatocytes and cytochrome P450-selective inhibitors predict variability in human drug exposure more accurately than human recombinant P450s. Br J Pharmacol 175: 2116-2129.
Lu X, Horner JW, Paul E, Shang X, Troncoso P, Deng P, et al. (2017). Effective combinatorial immunotherapy for castration-resistant prostate cancer. Nature 543: 728-732.
Murayama N, Yajima K, Hikawa M, Shimura K, Ishii Y, Takada M, et al. (2018). Assessment of multiple cytochrome P450 activities in metabolically inactivated human liver microsomes and roles of P450 2C isoforms in reaction phenotyping studies. Biopharm Drug Dispos 39: 116-121.
Ren HC, Sai Y, Chen T, Zhang C, Tang L, & Yang CG (2021). Predicting the Drug-Drug Interaction Mediated by CYP3A4 Inhibition: Method Development and Performance Evaluation. AAPS J 24: 12.
Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, et al. (2018). Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective. Clin Pharmacol Ther 104: 88-110.
Watanabe R, Kawata T, Ueda S, Shinbo T, Higashimori M, Natsume-Kitatani Y, et al. (2023). Prediction of the Contribution Ratio of a Target Metabolic Enzyme to Clearance from Chemical Structure Information. Mol Pharm 20: 419-426.
Yang X, Pfuma Fletcher E, Huang SM, Zineh I, & Madabushi R (2021). Regulatory Efforts to Facilitate Evaluation and Clinical Management of Drug-Drug Interaction Risks. Clin Pharmacol Ther 109: 42-46.
Youdim KA, Zayed A, Dickins M, Phipps A, Griffiths M, Darekar A, et al. (2008). Application of CYP3A4 in vitro data to predict clinical drug-drug interactions; predictions of compounds as objects of interaction. Br J Clin Pharmacol 65: 680-692.