Cut Point in Immunogenicity Testing: A Flawed Concept We Can Live Without [0.03%]
免疫原性试验中的截断点：一个可以没有的错误概念
Robert J Kubiak
Robert J Kubiak
The current paradigm for detection of anti-drug antibodies (ADA) recommends a tiered strategy in which samples are tested in consecutive screening and confirmatory assays to ensure high sensitivity and specificity of detection. In each tier...
Integrated Physiologically-Based Pharmacokinetic Model with a Quantitative Systems Pharmacology and Toxicology Model for Statins in Disease Population. Part 1: Model Development and Validation [0.03%]
基于生理的统计药物药代动力学模型与疾病人群中的系统药理和毒理模型整合研究（一）：建模与验证
Luna Prieto Garcia,Pär Nordell,Christine Ahlström et al.
Luna Prieto Garcia et al.
It is important to understand the key factors affecting the pharmacokinetics (PK), pharmacological response and toxicity of a drug to ensure clinical therapeutic efficacy and safety across disease populations. Traditionally, label dose-adju...
Ensuring Medical Product Patient Access Through Application of Recently Improved Global Chemistry, Manufacturing and Control Regulatory Frameworks: A Case Study Utilizing a Multi-Product PACMP [0.03%]
改进的全球质量、疗效和制造框架确保药品可及性的案例研究：以多产品PACMP为例
Sunny Kamlesh Dave,Christine Ørting,Scott W Roberts
Sunny Kamlesh Dave
The efficient review and approval of chemistry, manufacturing and control (CMC) post-approval changes by global health authorities remains a critical aspect toward ensuring medical product commercial supply chains and patient access. The re...
Clinical Ocular Exposure Extrapolation for an Ophthalmic Ointment Using PBPK Modeling and Simulation [0.03%]
基于生理药代动力学模型和模拟的翻白眼试验眼部暴露量外推研究
Maxime Le Merdy,Ming-Liang Tan,Viera Lukacova
Maxime Le Merdy
Generic ophthalmic drug product development is challenging, and innovative methodologies to complement traditional bioequivalence (BE) studies for BE assessment are desirable to promote their evaluation. Ocular physiologically based pharmac...
A Fit-for-purpose Strategy for Clinical Immunogenicity Assessment of Multivalent Bispecific Antibodies [0.03%]
适合目的的策略：多价双特异性抗体的临床免疫原性评估
Zhaojun Yin,Bob Y Liu,Ben Ordonia et al.
Zhaojun Yin et al.
Bispecific antibodies (BsAbs) have emerged as a promising class of therapeutics to treat complex diseases, offering advantages in dual targeting simultaneously compared to monospecific antibodies. However, BsAbs often require advanced engin...
Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays? [0.03%]
生物标志物测定验证与药代动力学测定验证的不同之处是什么？
Yan G Ni,Lauren F Stevenson,Lakshmi Amaravadi et al.
Yan G Ni et al.
Validation of a Göttingen Minipig Gene Therapy Biodistribution Assay for AVGN7 Using Droplet Digital Polymerase Chain Reaction [0.03%]
使用液滴数字聚合酶链反应对AVGN7进行哥廷根迷你猪基因治疗生物分布分析的验证研究
Agostinho G Rocha,Tony Yu,Magdalena Loveland et al.
Agostinho G Rocha et al.
Minipig models are rapidly gaining popularity in gene therapy preclinical studies. This includes biodistribution studies that are required by regulatory agencies, but are poorly described in the literature. This is particularly true for ddP...
One-step Immobilization of Human α-1-acid Glycoprotein on Magnetic Beads: A Rapid Method for Small Molecule hAGP Binding Study [0.03%]
一步合成将人α-1酸性糖蛋白固定于磁珠表面的方法及其在小分子hAGP结合研究中的应用
Ting Wang,Hamid Samareh Afsari,Steven Anderlot et al.
Ting Wang et al.
Human α-1-acid glycoprotein (hAGP) immobilized directly on NHS ester (N-hydroxysuccinimide) activated magnetic beads (hAGP-beads) was developed as a novel tool for studying small molecule hAGP binding. This method offers a straightforward,...
Technical Considerations of Pharmacokinetic Assays for LNP-mRNA Drug Products by RT-qPCR [0.03%]
RT-qPCR测定LNP-mRNA药物产品的药代动力学检体的技术考量
Jason Pennucci,Amanda Hays,Wendy Adamowicz et al.
Jason Pennucci et al.
Lipid nanoparticle-messenger RNA (LNP-mRNA) drug products are a growing class of drug modalities. The unique composition of these drug products requires multiple measurements to account for the different components of these drug modalities....