[HTML][HTML] Model-informed precision dosing: State of the art and future perspectives

IK Minichmayr, E Dreesen, M Centanni, Z Wang… - Advanced drug delivery …, 2024‏ - Elsevier
Abstract Model-informed precision dosing (MIPD) stands as a significant development in
personalized medicine to tailor drug dosing to individual patient characteristics. MIPD moves …

Realizing the promise of project optimus: challenges and emerging opportunities for dose optimization in oncology drug development

W Gao, J Liu, B Shtylla… - CPT …, 2024‏ - Wiley Online Library
Project Optimus is a US Food and Drug Administration Oncology Center of Excellence
initiative aimed at reforming the dose selection and optimization paradigm in oncology drug …

[HTML][HTML] Integrated modeling of biomarkers, survival and safety in clinical oncology drug development

H Liu, EIK Ibrahim, M Centanni, C Sarr… - Advanced Drug Delivery …, 2024‏ - Elsevier
Abstract Model-based approaches, including population pharmacokinetic-
pharmacodynamic modeling, have become an essential component in the clinical phases of …

US Food and Drug Administration embraces using innovation to identify optimized dosages for patients with cancer

SS Shord, H Zhu, J Liu, A Rahman… - CPT …, 2023‏ - pmc.ncbi.nlm.nih.gov
Given evidence that currently used dosing regimens are not tolerable for many patients with
cancer, the public has expressed an urgent need to optimize dosages for oncology drugs …

Confounded exposure metrics

MR Wiens, JL French… - CPT: Pharmacometrics & …, 2023‏ - pmc.ncbi.nlm.nih.gov
Exposure-response (ER) modeling frequently relies on the use of exposure metrics that
summarize drug concentrations over time. We present simulations to demonstrate that …

Model‐Based Benefit/Risk Analysis for the Copanlisib Intermittent Dosing Regimen

PN Morcos, J Moss, J Veasy… - Clinical …, 2024‏ - Wiley Online Library
Copanlisib is an intravenously administered phosphatidylinositol 3‐kinase (PI3K) inhibitor,
which is approved as monotherapy for relapsed follicular lymphoma in adult patients who …

Development of a generalized pharmacokinetic model to characterize clinical pharmacokinetics of monomethyl auristatin E‐based antibody–drug conjugates

HP Chang, YK Cheung, S Liu… - British Journal of Clinical …, 2024‏ - Wiley Online Library
Aims This study aims to develop a generalized pharmacokinetic (PK) model for monomethyl
auristatin E (MMAE)‐based antibody–drug conjugates (ADCs) that can simultaneously …

In silico trial for the assessment of givinostat dose adjustment rules based on the management of key hematological parameters in polycythemia vera patients

EM Tosca, A De Carlo, R Bartolucci… - CPT …, 2024‏ - Wiley Online Library
Polycythemia vera (PV) is a chronic myeloproliferative neoplasm characterized by excessive
levels of platelets (PLT), white blood cells (WBC), and hematocrit (HCT). Givinostat …

Exposure-response–based multiattribute clinical utility score framework to facilitate optimal dose selection for oncology drugs

Y Cheng, S Chu, J Pu, M Chen, K Hong… - Journal of Clinical …, 2024‏ - ascopubs.org
PURPOSE The advent of new therapeutic modalities highlighted deficiencies in the
traditional maximum tolerated dose approach for oncology drug dose selection and …

Trilaciclib dosage in Chinese patients with extensive-stage small cell lung cancer: a pooled pharmacometrics analysis

H Dai, Y Yang, C Wang, Y Chen, Y Cui, P Li… - Acta Pharmacologica …, 2024‏ - nature.com
This study aimed to analyze potential ethnic disparities in the dose–exposure–response
relationships of trilaciclib, a first-in-class intravenous cyclin-dependent kinase 4/6 inhibitor …