Case Studies on the Use of Patient-centric Sampling for Clinical Studies in Pharmaceutical Drug Development [0.03%]
以患者为中心的抽样在药物研发中的临床研究案例分析
Shefali Patel,Mike Baratta,Peter Bryan et al.
Shefali Patel et al.
The current gold standard of blood sample collection in clinical trials involves venous draws performed by trained phlebotomists in clinical settings. However, recent technological advancements have enabled the emergence of patient-centric ...
Assessment of Neutralizing Antibody Activity in Clinical Studies: Use of Surrogate Measurements Instead of Stand-alone Assays [0.03%]
临床研究中评估中和抗体活性：使用替代测量方法而非单独的试验检测
Michael A Partridge,Lynn Kamen,Bonnie Wu et al.
Michael A Partridge et al.
Neutralizing antibodies (NAbs) to protein therapeutics have traditionally been assumed to be the most impactful subset of anti-drug-antibodies (ADA). NAbs can block the biotherapeutic from engaging its target impacting efficacy and may also...
Optimization of In Vitro CYP3A4 TDI Assay Conditions and Use of Derived Parameters for Clinical DDI Risk Assessment Using Static and Dynamic Models [0.03%]
基于静态和动态模型的临床药物相互作用风险评估及体外CYP3A4 TDI测定条件的优化研究
Alessandra Pugliano,Aynur Ekiciler,Lena Preiss et al.
Alessandra Pugliano et al.
Cytochrome P450 3A4 (CYP3A4) is a key target for time-dependent inhibition (TDI) assessment during drug development. However, translating in vitro TDI data to in vivo drug-drug interaction (DDI) risk remains challenging due to the acknowled...
Novel Pharmacokinetic Bridging Strategy for Locally Acting Intravitreal Drug Products [0.03%]
用于局部作用玻璃体内给药产品的新型药代动力学桥接策略
Ping Ji,William M Boyd,Chandrahas Sahajwalla
Ping Ji
A clinical development program for follow-on locally acting intravitreal drug products typically includes a comparative efficacy study. Pharmacokinetic assessment is often considered of limited value because systemic exposure is low and/or ...
A Microemulsion for Oral Delivery of Nintedanib - QbD-Enabled Formulation Development, In-Vitro Characterization & In-Vivo Pharmacokinetic Assessment [0.03%]
用于口服递送尼替尼的微型乳液的研发：基于质量设计（QbD）的方法、体外特征分析及药代动力学评估
Dnyandev Gadhave,Mural Quadros,Mimansa Goyal et al.
Dnyandev Gadhave et al.
Nintedanib (Nint) is a potent tyrosine kinase inhibitor recently approved by the US FDA to treat idiopathic pulmonary fibrosis (IPF). Delivery of Nint through available approaches is highly challenging because of its poor solubility and rap...
Long-term Storage Stability of Inhalable Phage Powder Formulations: A Four-Year Study [0.03%]
吸入用噬菌体粉剂的长期贮存稳定性研究——一项为期四年的研究
Mengyu Li,Wei-Ren Ke,Rachel Yoon Kyung Chang et al.
Mengyu Li et al.
The growing potential of bacteriophage therapy as an alternative treatment for pulmonary infections caused by multidrug-resistant bacteria has been increasingly recognized. This study aimed to evaluate the long-term stability of spray-dried...
Correction: Cellular Kinetics and Biodistribution of Adoptive T Cell Therapies: from Biological Principles to Effects on Patient Outcomes [0.03%]
关于过继性T细胞治疗的细胞动力学和生物分布的纠正：从生物学原理到对患者结局的影响
Ran Li,Abigail K Grosskopf,Louis R Joslyn et al.
Ran Li et al.
Published Erratum
The AAPS journal. 2025 Jul 31;27(5):127. DOI:10.1208/s12248-025-01108-8 2025
Development of a Multi-Purpose Comprehensive Physiologically Based Pharmacokinetic Model for Crizotinib: An Example Application in Bioequivalence Assessment between Oral Solution and Granules in Pediatric Subjects [0.03%]
一种克唑替尼多用途综合生理药动学模型的开发：在儿科受试者中评估口服溶液和颗粒的生物等效性的示例应用
Kazuko Sagawa,Vivek Purohit,Vu Le et al.
Kazuko Sagawa et al.
Crizotinib exhibits a complex drug-drug interaction as it is a CYP3A4 substrate and acts as both a time-dependent inhibitor and inducer of the enzyme. Absorption of crizotinib is also complex as it exhibits a prolonged absorption phase. The...
Population Pharmacokinetic Modeling of Amoxicillin in Plasma and Milk in Lactating Göttingen Minipigs - A Contribution from the ConcePTION Project [0.03%]
来源于ConcePTION项目的新生 Göttigen 乳猪血浆和乳中氨苄西林群体药代动力学模型研究
Miao-Chan Huang,Julia Macente,Nina Nauwelaerts et al.
Miao-Chan Huang et al.
Background: Amoxicillin is frequently prescribed to peripartum women as prophylaxis and treatment for infection. Despite frequent usage of amoxicillin in lactating women, quantitative evidence regarding its transfer betwe...
Machine Learning Predicts Drug Release Profiles and Kinetic Parameters Based on Tablets' Formulations [0.03%]
基于药片配方的机器学习预测药物释放曲线及动力学参数
Chrystalla Protopapa,Angeliki Siamidi,Amelia Adibe Eneli et al.
Chrystalla Protopapa et al.
Direct compression (DC) remains a popular manufacturing technology for producing solid dosage forms. However, the formulation optimisation is a laborious process, costly and time-consuming. The aim of this study was to determine whether mac...