Correction: Establishing Clinically Relevant Specifications for Carbamazepine Tablets Using Physiologically Based Pharmacokinetic Modeling [0.03%]
基于生理的药代动力学建模建立卡马西平片临床相关标准的订正论文
Xiaofeng Wang,Longjie Li,Hongyi Yang et al.
Xiaofeng Wang et al.
Published Erratum
The AAPS journal. 2025 Jun 4;27(4):103. DOI:10.1208/s12248-025-01085-y 2025
A Bottom-up Approach for Mutant and Wild Type Collies Using Physiologically Based Pharmacokinetic (PBPK) Modeling: A Case Study Using Loperamide [0.03%]
基于生理的药代动力学（PBPK）模型自下而上方法对麦町狗突变体和野生型品系用药的研究：洛哌丁胺案例研究
Charlotte Cross,Marilyn N Martinez,Devendra Pade et al.
Charlotte Cross et al.
A bottom-up physiologically based pharmacokinetic (PBPK) model was developed to predict the pharmacokinetics of loperamide, a substrate for multidrug resistance 1 (Mdr1) encoded P-glycoprotein (P-gp), in wild-type dogs (WT) and dogs that ar...
Evaluating the Impact of AI-Based Model-Informed Drug Development (MIDD): A Comparative Review [0.03%]
基于人工智能的模型引导药物开发(MIDD)的影响评估：比较回顾
Bingyu Mao,Yue Gao,Christine Xu et al.
Bingyu Mao et al.
Model-informed drug development (MIDD) methods play critical role to ensure development of efficacious, and safe individualized therapies. The application of artificial intelligence/machine learning (AI/ML) within the field of drug developm...
A Comparative Study on Physicochemical and Analytical Characterizations of Doxil® and its Generic Drug Products [0.03%]
道诺药和其仿制药的理化及分析特性比较研究
Adaeze Eneli,Kaikai Wang,Jingyao Gan et al.
Adaeze Eneli et al.
Doxil®, a PEGylated liposomal doxorubicin (DOX) hydrochloride suspension, was the first liposome drug product approved by the U.S. Food and Drug Administration (FDA). Although off-patent, limited generic products have been approved due to ...
Comparative Study
The AAPS journal. 2025 Jun 2;27(4):100. DOI:10.1208/s12248-025-01058-1 2025
Application of Real-World Evidence to Support FDA Regulatory Decision Making [0.03%]
真实世界证据在支持FDA监管决策中的应用
Vipada Khaowroongrueng,Tae-Eun Kim,Sang-In Park et al.
Vipada Khaowroongrueng et al.
Real-world data (RWD) and real-world evidence (RWE) are valuable resources for drug development strategies. Historically, it has been used for safety evaluation during post-marketing surveillance. RWD and RWE have been utilized in the regul...
Publisher Correction: Generating Realistic Albumin Concentrations in Virtual Subjects Across A Spectrum of Renal Function to Account for Variability in Protein Binding Within PBPK Models [0.03%]
出版社更正：生成虚拟受试者的真实白蛋白浓度，在整个肾功能范围内为PBPK模型中的蛋白质结合变化提供依据
Yuming Hu,Daniel Scotcher
Yuming Hu
Published Erratum
The AAPS journal. 2025 May 28;27(4):99. DOI:10.1208/s12248-025-01089-8 2025
Risk Assessment for Biopharmaceutics Classification System Class IV Molecule Containing Immediate Release Products: Use of In-Silico Prediction Tools and Physiologically Based Pharmacokinetic Modeling [0.03%]
生物药剂学分类系统第IV类分子的即时释放产品的风险评估：利用计算机预测工具和生理药代动力学建模
Sivacharan Kollipara,Mahendra Chougule,Karthik Parsa et al.
Sivacharan Kollipara et al.
Nitrosamines drug substance related impurities (NDSRI) are organic impurities, highly potent mutagenic substances that are classified as human carcinogens. Regulatory guidance's in this area provide procedures for control and risk mitigatio...
Improvement of Drug Release from an Aptamer Drug Conjugate Using Reductive-sensitive Linkers for Tumor-targeted Drug Delivery [0.03%]
基于还原敏感连接子的适配体-药物共轭物用于肿瘤靶向治疗的研究
You Wu,Yusuke Kawamoto,Jin Sun et al.
You Wu et al.
The selective delivery of small molecule compounds such as Gemcitabine to tumor cells is a promising methodology for enhancing therapeutic efficacy and attenuating the side effects of anticancer drugs. Aptamers are useful as target-directed...
Rethinking Pharmaceutical Industry with Quality by Design: Application in Research, Development, Manufacturing, and Quality Assurance [0.03%]
基于质量设计的药物研发质量管理杂谈
Joana Galvão Duarte,Maria Galvão Duarte,Ana Paula Piedade et al.
Joana Galvão Duarte et al.
Quality by Design (QbD) is a transformative and systematic approach to developing top-tier pharmaceutical products, ushering in a departure from traditional trial-and-error methods toward a more science-based, risk-oriented, and holistic st...
Publisher Correction: Simultaneous Estimation of fm and FG Values Directly from Clinical Drug-Drug Interaction Study Data [0.03%]
出版更正：从临床药物相互作用研究数据直接估算fm和FG值
Yumi Cleary,Nicolo Milani,Kayode Ogungbenro et al.
Yumi Cleary et al.
Published Erratum
The AAPS journal. 2025 May 16;27(4):92. DOI:10.1208/s12248-025-01081-2 2025