Under the umbrella of clinical pharmacology: inflammatory bowel disease, infliximab and adalimumab, and a bridge to an era of biosimilars

Z Petric, J Goncalves, P Paixao - Pharmaceutics, 2022 - mdpi.com
Monoclonal antibodies (MAbs) have revolutionized the treatment of many chronic
inflammatory diseases, including inflammatory bowel disease (IBD). IBD is a term that …

Opportunities and challenges for PBPK model of mAbs in paediatrics and pregnancy

KL Gill, HM Jones - The AAPS Journal, 2022 - Springer
New drugs may in some cases need to be tested in paediatric and pregnant patients.
However, it is difficult to recruit such patients and there are many ethical issues around their …

Optimizing therapeutic drug monitoring in inflammatory bowel disease: a focus on therapeutic monoclonal antibodies

K Papamichael, AS Cheifetz - Expert Opinion on Drug Metabolism …, 2021 - Taylor & Francis
Introduction Therapeutic drug monitoring (TDM) is useful for optimizing monoclonal
antibodies (mAbs) for the treatment of immune-mediated inflammatory disorders including …

Application of physiologically based pharmacokinetic models for therapeutic proteins and other novel modalities

RH Rose, A Sepp, F Stader, KL Gill, C Liu, I Gardner - Xenobiotica, 2022 - Taylor & Francis
The past two decades have seen diversification of drug development pipelines and
approvals from traditional small molecule therapies to alternative modalities including …

Physiologically based pharmacokinetic modelling of semaglutide in children and adolescents with healthy and obese body weights

TR Machado, T Honorio… - British Journal of …, 2023 - Wiley Online Library
Aims To develop paediatric physiologically based pharmacokinetic modelling (PBPK)
models of semaglutide to estimate the pharmacokinetic profile for subcutaneous injections in …

英夫利西单抗用于克罗恩病患者的治疗药物监测研究进展

朱扣柱, 王燕, 缪丽燕 - 中国药房, 2023 - journal.china-pharmacy.com
英夫利西单抗(IFX) 是目前临床广泛用于治疗克罗恩病(CD) 的肿瘤坏死因子α 抑制剂,
但其常规剂量难以获得较佳疗效, 建议疗效欠佳的患者进行治疗药物监测(TDM) …

Outcomes in Adult Inflammatory Bowel Disease Clinical Trials: Assessment of Similarity Among Participants with Adolescent-onset and Adult-onset Disease

JR Rosh, D Turner, JS Hyams… - Journal of Crohn's …, 2024 - academic.oup.com
Abstract Background and Aims Most paediatric inflammatory bowel disease [IBD] studies are
performed after medications are approved in adults, and the majority of participants in these …

Advances in therapeutic drug monitoring of infliximab in patients with Crohn disease

K Zhu, Y Wang, L Miao - China Pharmacy, 2023 - pesquisa.bvsalud.org
Infliximab (IFX), tumor necrosis factor-α inhibitor, is widely used in clinical practice for
treating Crohn disease (CD), but it is difficult to obtain the optimal therapeutic effect …

Model-informed precision dosing of infliximab to improve outcomes of individual patients with inflammatory bowel diseases

W Kantasiripitak, E Dreesen, M Ferrante, D Thomas - 2023 - lirias.kuleuven.be
Background For over two decades, the 5 mg/kg weight-based dosing of infliximab was
approved for inducing and maintaining remission in all patients with moderate-to-severe …

[引用][C] Mathematical models to characterize the absorption, distribution, metabolism, and excretion of protein therapeutics

S Liu, DK Shah - Drug Metabolism and Disposition, 2022 - ASPET