Editor's note on the themed issue: assessing QSP models and amplifying their impact [0.03%]
本期专题编辑前言：评估定量和资格化模型并扩大其影响范围
Abhishek Gulati,Jessica Brady
Abhishek Gulati
Recommendations for a standardized publication protocol for a QSP model [0.03%]
关于发布定量-定性结合模型的标准化出版规范建议
Jared Weddell,Abhishek Gulati,Akihiro Yamada
Jared Weddell
Development of a Quantitative Systems Pharmacology (QSP) model is a long process with many iterative steps. Lack of standard practices for publishing QSP models has resulted in limited model reproducibility within the field. Multiple studie...
Computing optimal drug dosing regarding efficacy and safety: the enhanced OptiDose method in NONMEM [0.03%]
关于疗效和安全性的最优药物剂量计算：NONMEM中的增强OptiDose方法
Freya Bachmann,Gilbert Koch,Robert J Bauer et al.
Freya Bachmann et al.
Recently, an optimal dosing algorithm (OptiDose) was developed to compute the optimal drug doses for any pharmacometrics model for a given dosing scenario. In the present work, we enhance the OptiDose concept to compute optimal drug dosing ...
Population pharmacokinetic analyses of pozelimab in patients with CD55-deficient protein-losing enteropathy (CHAPLE disease) [0.03%]
用于治疗CD55缺乏性肠内蛋白丢失症（CHAPLE疾病）的Pozelimab药代动力学分析
Kuan-Ju Lin,Jeanne Mendell,John D Davis et al.
Kuan-Ju Lin et al.
Pozelimab, a monoclonal antibody directed against C5, is the first and only treatment for adult and pediatric patients (≥ 1 year) with CD55-deficient protein-losing enteropathy (CHAPLE) disease. A target-mediated drug disposition (TMDD) po...
Population pharmacokinetics and exposure-response relationships of maribavir in transplant recipients with cytomegalovirus infection [0.03%]
移植受者中马里巴韦的群体药代动力学及暴露反应关系研究
Ivy H Song,Grace Chen,Siobhan Hayes et al.
Ivy H Song et al.
Maribavir is approved for management of post-transplant cytomegalovirus (CMV) infections refractory and/or resistant to CMV therapies at a dose of 400 mg twice daily (BID). Population pharmacokinetic (PopPK) and exposure-response analyses w...
Arian Emami Riedmaier,Robert Bies
Arian Emami Riedmaier
Generative models for synthetic data generation: application to pharmacokinetic/pharmacodynamic data [0.03%]
生成合成数据的生成模型：药代动力学/药效学数据的应用
Yulun Jiang,Alberto García-Durán,Idris Bachali Losada et al.
Yulun Jiang et al.
The generation of synthetic patient data that reflect the statistical properties of real data plays a fundamental role in today's world because of its potential to (i) be enable proprietary data access for statistical and research purposes ...
A review of the physiological effects of microgravity and innovative formulation for space travelers [0.03%]
微重力的生理影响及航天员用药创新剂型研究进展
Jey Kumar Pachiyappan,Manali Patel,Parikshit Roychowdhury et al.
Jey Kumar Pachiyappan et al.
During the space travel mission, astronauts' physiological and psychological behavior will alter, and they will start consuming terrestrial drug products. However, factors such as microgravity, radiation exposure, temperature, humidity, str...
Chuanpu Hu,Anna G Kondic,Amit Roy
Chuanpu Hu
Visual predictive checks (VPC) are commonly used to evaluate pharmacometrics models. However their performance may be hampered if patients with worse outcomes drop out earlier, as often occurs in clinical trials, especially in oncology. Whi...
General quasi-equilibrium multivalent binding model to study diverse and complex drug-receptor interactions of biologics [0.03%]
用于研究生物制剂多样且复杂的药物-受体相互作用的广义准平衡多元结合模型
Chee M Ng,Robert J Bauer
Chee M Ng
Pharmacokinetics and pharmacodynamics of many biologics are influenced by their complex binding to biological receptors. Biologics consist of diverse groups of molecules with different binding kinetics to its receptors including IgG with si...