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Role of Modelling and Simulation in Regulatory Decision Making in Europe. Get just this article for as long as you need it. Kerioui M, Bertrand J, Bruno R, Mercier F, Guedj J, Desmée S. Modelling the association between biomarkers and clinical outcome: An introduction to nonlinear joint models. Get answers and explanations from our Expert Tutors, in as fast as 20 minutes. Ethics declarations. Anti-cancer treatment schedule optimization based on tumor dynamics modelling incorporating evolving resistance. Evaluation of tumor size response metrics to predict overall survival in Western and Chinese patients with first-line metastatic colorectal cancer. Colomban O, Tod M, Leary A, Ray-Coquard I, Lortholary A, Hardy-Bessard AC, et al. Bratman SV, Yang SYC, Lafolla MAJ, Liu Z, Hansen AR, Bedard PL, et al. Concept development practice page 8.1.7. Prices may be subject to local taxes which are calculated during checkout. Gong Y, Mason J, Shen YL, Chang E, Kazandjian D, Blumenthal GM, et al. Evaluation of continuous tumor-size-based end points as surrogates for overall survival in randomized clinical trials in metastatic colorectal cancer.
Beumer JH, Chu E, Salamone SJ. Industrial perspective on the benefits realized from the FDA's model-informed drug development paired meeting pilot program. Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, et al. "; accessed October 14, 2022. CtDNA predicts overall survival in patients with NSCLC treated with PD-L1 blockade or with chemotherapy. Support to early clinical decisions in drug development and personalised medicine with checkpoint inhibitors using dynamic biomarker-overall survival models | British Journal of Cancer. Measuring response in a post-RECIST world: from black and white to shades of grey. Janssen JM, Verheijen RB, van Duijl TT, Lin L, van den Heuvel MM, Beijnen JH, et al. Stat Methods Med Res. Krishnan SM, Friberg LE, Mercier F, Zhang R, Wu B, Jin JY, et al. This is a preview of subscription content, access via your institution. Wilkerson J, Abdallah K, Hugh-Jones C, Curt G, Rothenberg M, Simantov R, et al. These pharmacological endpoints like tumour dynamic (tumour growth inhibition) metrics have been proposed as alternative endpoints to complement the classical RECIST endpoints (objective response rate, progression-free survival) to support early decisions both at the study level in drug development as well as at the patients level in personalised therapy with checkpoint inhibitors. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab.
This perspective paper presents recent developments and future directions to enable wider and robust use of model-based decision frameworks based on pharmacological endpoints. Received: Revised: Accepted: Published: DOI: Burzykowski T, Coart E, Saad ED, Shi Q, Sommeijer DW, Bokemeyer C, et al. Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, et al. All optimal dosing roads lead to therapeutic drug monitoring—why take the slow lane. New concept chapter 8. Lone SN, Nisar S, Masoodi T, Singh M, Rizwan A, Hashem S, et al. Answer & Explanation. Additional information.
Michaelis LC, Ratain MJ. Competing interests. Chanu P, Wang X, Li Z, Chen S-C, Samineni D, Susilo M, et al. Evaluation of salivary exosomal chimeric GOLM1-NAA35 RNA as a potential biomarker in esophageal carcinoma. 2022;Abstr 10276.. What is a concept development. Sheiner LB. Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer: a retrospective analysis. JG declares no competing interests. Multistate pharmacometric model to define the impact of second-line immunotherapies on the survival outcome of IMpower131 study.
Tumor dynamic model-based decision support for Phase Ib/II combination studies: a retrospective assessment based on resampling of the Phase III study IMpower150. Dynamic changes of circulating tumor DNA predict clinical outcome in patients with advanced non-small-cell lung cancer treated with immune checkpoint inhibitors.
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