Nitrogen-containing heterocyclic drug products approved by the FDA in 2023: Synthesis and biological activity

W Luo, Y Liu, H Qin, Z Zhao, S Wang, W He… - European Journal of …, 2024 - Elsevier
This article profiles 13 newly approved nitrogen-containing heterocyclic drugs by the US
Food and Drug Administration (FDA) in 2023. These drugs target a variety of therapeutic …

[HTML][HTML] The Role of Pharmacometrics in Advancing the Therapies for Autoimmune Diseases

A Świerczek, D Batko, E Wyska - Pharmaceutics, 2024 - mdpi.com
Autoimmune diseases (AIDs) are a group of disorders in which the immune system attacks
the body's own tissues, leading to chronic inflammation and organ damage. These diseases …

Virtual bioequivalence assessment of Ritlecitinib capsules with incorporation of observed clinical variability using a physiologically based pharmacokinetic model

A Saadeddin, V Purohit, Y Huh, M Wong, A Maulny… - The AAPS Journal, 2024 - Springer
Ritlecitinib, an orally available Janus kinase 3 and tyrosine kinase inhibitor being developed
for the treatment of alopecia areata (AA), is highly soluble across the physiological pH range …

A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata

S Anderson, G Cavaletti, LJ Hood… - Pharmacology …, 2024 - Wiley Online Library
Reversible axonal swelling and brainstem auditory evoked potential (BAEP) changes were
observed in standard chronic (9‐month) toxicology studies in dogs treated with ritlecitinib, an …

Model‐Informed Assessment of Probability of Phase 3 Success for Ritlecitinib in Patients with Moderate‐to‐Severe Ulcerative Colitis

J Wojciechowski, A Mukherjee… - Clinical …, 2024 - Wiley Online Library
Ritlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma
family inhibitor, was evaluated in patients with ulcerative colitis (UC) in a phase 2b trial …

Moving Beyond Boundaries: Utilization of Longitudinal Exposure–Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug …

Y Huh, J Wojciechowski, VS Purohit - Clinical Pharmacokinetics, 2024 - Springer
Abstract Background and Objectives As drug development scientists strive to accelerate
availability of therapies for patients, model-informed drug development (MIDD) plays an …

[HTML][HTML] 药物代谢动力学的研究进展

郭晔, 陈建平, 成日青, 徐长进, 王来兵, 马岚… - Journal of Advances in …, 2023 - hanspub.org
药物代谢动力学是药理学和生物药剂学学科中的重要研究内容, 已成为制备药物新制剂必须研究
的部分. 本文通过查阅近年来国内外相关文献, 对药物代谢动力学的参数, 药物应用的药动学基础 …