采用GastroPlus 软件发表的部分参考文献汇总 （2024年7-12月）

采用基于生理的生物药剂学PBBM模型建立他克莫司缓释胶囊的具有生物预测力的溶出方法和生物等效性的安全空间

Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules

Bi F, Yuan T, Zhang B. et al. AAPS PharmSciTech. Volume 26, article number 13, (2025)

使用生理药代动力学模型评估克拉霉素与直接口服抗凝剂之间的药物相互作用

Evaluation of Drug–Drug Interactions Between Clarithromycin and Direct Oral Anticoagulants Using Physiologically Based Pharmacokinetic Models

Yang Z, Qu Y, Sun Y. et al. Pharmaceutics. 2024, 16(11), 1449

伏立康唑在人中枢神经系统中的生理药代动力学模型——整合CYP3A4的时间依赖性抑制、CYP2C19的遗传多态性和可能的转运体机制

A Physiologically Based Pharmacokinetic Model of Voriconazole in Human CNS —— Integrating Time-Dependent Inhibition of CYP3A4, Genetic Polymorphisms of CYP2C19 and Possible Transporter Mechanisms

Dong L, Zhuang X, Yang T. et al. Int J Antimicrob Agents. Volume 64, Issue 4, October 2024, 107310

胰高血糖素样肽-1受体3-苯基氧杂环丁烷衍生物激动剂的设计和评价

Design and Evaluation of 3-Phenyloxetane Derivative Agonists of the Glucagon-Like Peptide-1 Receptor

Zhang Z, Pan H, Guo L. et al. J Med Chem. 2024, 67, 17, 14820–14839

虚拟药物研究在新药研发中的应用：挑战与机遇

Application of Virtual Drug Study to New Drug Research and Development: Challenges and Opportunity

Li X, Liu S, Liu D. et al. Clin Pharmacokine.t Volume 63, pages 1239–1249, (2024)

使用生理药代动力学模型预测鸡血藤活性成分的药代动力学

Predicting Pharmacokinetics of Active Constituents in Spatholobi caulis by Using Physiologically Based Pharmacokinetic Models

Liu X, Du R, Zhang T. et al. Pharmaceuticals. 2024, 17(12), 1621

NH130的I期临床试验及使用生理药代动力学模型预测其药代动力学

Phase I clinical trial of NH130 and the prediction of its pharmacokinetics using physiologically based pharmacokinetic modeling

Kun Zhang, Shanshan Zhao, Jialin Du, Lan Zhang. Frontiers in Pharmacology. Volume 15 - 2024

使用PBPK模型表征ARV-471的临床前放射性ADME特性，从而预测人体 PK

Characterization of preclinical radio ADME properties of ARV-471 for predicting human PK using PBPK modeling

Yifei He, Chenggu Zhu, Peng Lei. et al. Journal of Pharmaceutical Analysis. Available online 28 December 2024, 101175

采用生理药代动力学建模确认 CYP3A1/2 和 P-gp在大鼠甘草酸和乌头碱解毒机制中的作用

Physiologically based pharmacokinetic modeling for confirming the role of CYP3A1/2 and P-glycoprotein in detoxification mechanism between glycyrrhizic acid and aconitine in rats

Jingyi Jin, Xiaoqing Xu, Fengling Li. et al. J Appl Toxicol. 2024 Jul;44(7):978-989. doi: 10.1002

生理药代动力学模型在毒品研究中的应用

曾宪彬，王丹，李凯茜，严方 ，徐鹏. 《中国药物依赖性杂志》 Chin J Drug Depend  2024，33( 6) : 451-457

中国成人磷酸三(2-氯乙基)酯的生理毒代动力学(PBTK)模型构建

彭宇，施妙盈，贾旭东，周萍萍，曹佩，王霞，王子健. 《生态毒理学报》.2024

推进系统毒性风险评估：考察基于NAM的工具箱方法

Advancing Systemic Toxicity Risk Assessment: Evaluation of a NAM-based Toolbox Approach

Cable S, Baltazar MT, Bunglawala F et al. Toxicological Sciences. 18 December 2024

眼部建模和模拟的研究进展：关键考虑因素和应用案例

Advancements in Ocular Modelling and Simulations: Key Considerations and Case Studies

Khan MS, Murthy A, Ahmed T. AAPS PharmSciTech. Volume 26, article number 14, (2025)

基于生理学的生物药剂学建模 (PBBM) 应用的现状和新视野：研讨会汇总报告

Current State and New Horizons in Applications of Physiologically Based Biopharmaceutics Modeling (PBBM): A Workshop Report

Tannergren C, Arora S, Babiskin A. et al. Mol. Pharmaceutics. 2024.

基于生理学的生物药剂学建模与具有生物预测力溶出方法相结合：开发生物等效性制剂的美沙拉嗪肠溶片处方：一个棘手的难题

Physiologically Based Biopharmaceutics Modeling Coupled with Biopredictive Dissolution in Development of Bioequivalent Formulation for Mesalamine Enteric Coated Tablet: A Tough Nut to Crack

Kollipara S, Prabhat PK, Saha P. et al. AAPS PharmSciTech. Volume 26, article number 1, (2025)

用于持续输送治疗剂的水凝胶

Hydrogel for Sustained Delivery of Therapeutic Agents

Musuc AM, Mititelu M, Chelu M. Gels. 2024, 10(11), 717

基于载甲氧氯普胺埃洛石纳米管 (HNT) 的药物粘合剂型透皮给药系统的制剂处方开发、特性和机制性PBPK 建模

Formulation development, characterization, and mechanistic PBPK modeling of metoclopramide loaded halloysite nanotube (HNT) based drug-in-adhesive type transdermal drug delivery system

Parkash M, Shoaib MH, Sikandar M. et al. Scientific Reports. volume 14, Article number: 28512 (2024)

减肥患者的勃起功能障碍治疗：胃袖状切除术/绕道手术前后，他达拉非生物药剂学和药代动力学

Erectile Dysfunction Therapy of Bariatric Patients: Tadalafil Biopharmaceutics and Pharmacokinetics Before vs. After Gastric Sleeve/Bypass

Porat D, Dukhno O, Cvijić S. et al. The AAPS Journal. Volume 26, article number 114, (2024)

Trofinetide 在中度肾功能不全患者中的PBPK建模，经模型验证后用于I期临床研究的剂量选择

Physiologically-Based Pharmacokinetic Modeling of Trofinetide in Moderate Renal Impairment for Phase 1 Clinical Study Dose Selection with Model Validation

Darwish M, Marbury TC, Nunez R. et al. European Journal of Drug Metabolism and Pharmacokinetics. 08 November 2024

使用新型的isatin衍生物的Hansen 参数和 GastroPlus 构建的模型辅助优化用于治疗乳腺癌的局部弹性脂质体

Hansen parameters and GastroPlus assisted optimized topical elastic liposomes to treat breast cancer using a novel isatin derivative

Altamimi MA, Hussain A, Alanazi MM. et al. Arabian Journal of Chemistry. Volume 17, Issue 12, December 2024, 106028

仿制药开发早期阶段使用机器学习驱动生物等效性风险开展评估

Machine learning driven bioequivalence risk assessment at an early stage of generic drug development

Krajcar D, Velušček D, Grabnar I. European Journal of Pharmaceutics and Biopharmaceutics. Volume 205, December 2024, 114553

制定筛选策略以鉴定植物药的肝毒性和药物相互作用潜力

Developing a Screening Strategy to Identify Hepatotoxicity and Drug Interaction Potential of Botanicals

Roe AL, Krzykwa J, Calderón AI. et al. J Diet Suppl. Volume 22, 2025

口服吸入和鼻腔药物药品的生物等效性要求以及使用新型基于生理学的生物药剂学建模方法评估这些药物的体内性能

Bioequivalence Requirements for Orally Inhaled and Nasal Drug Products and Use of Novel Physiologically Based Biopharmaceutics Modeling Approaches for Assessing In Vivo Performance

Rachapally A, Boddu R, Kollipara S. et al. Journal of Pharmaceutical Sciences. 15 October 2024

使用基于生理学的生物药剂学模型证明迟释制剂溶出标准的扩大

Justification of widened dissolution specifications of an extended-release product using physiologically based biopharmaceutics modeling

Bhattiprolu AK, Kollipara S, Boddu R et al. Xenobiotica. Volume 54, 2024

PI3Kα选择性抑制剂inavolisib的临床前评估及其在人体的药代动力学和有效剂量的预测

Preclinical assessment of the PI3Kα selective inhibitor inavolisib and prediction of its pharmacokinetics and efficacious dose in human

Salphati L, Pang J, Plise EG. et al. Xenobiotica. Volume 54, 2024

对基于生理药代动力学模型的虚拟人群体生成和验证方法的批判性评论：方法论、案例研究和未来发展方向

A critical review on approaches to generate and validate virtual population for physiologically based pharmacokinetic models: Methodologies, case studies and way forward

Chougule M, Kollipara S, Mondal S. et al. Eur J Clin Pharmacol. Volume 80, pages 1903–1922, (2024)

PBBM中基础模型、模型验证和应用步骤的考虑：研讨会总结报告

PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report

Heimbach T, Musuamba Tshinanu F, Raines K. et al. Mol. Pharmaceutics. 2024, 21, 11, 5353–5372

通过产品质量研究所 (PQRI) 联盟促进有生物预测力方法的协调：双嘧达莫片的有生物预测力溶出方法

Advancing the Harmonization of Biopredictive Methodologies through the Product Quality Research Institute (PQRI) Consortium: Biopredictive Dissolution of Dipyridamole Tablets

Tsume Y, Ashworth L, Bermejo Sanz M. et al. Mol Pharm. 2024, 21, 10, 5315–5325

使用生理药代动力学建模和模拟开展唑吡坦在女性患者的剂量调整研究

In Silico Dose Adjustment of Zolpidem in Females Using Physiologically Based Pharmacokinetic Modeling and Simulations

Malayandi R, Karmakar A, Dhake P. et al. Sleep Vigilance. Volume 8, pages 251–263, (2024)

鼻腔混悬喷雾剂的CFD-PK 模型：使用曲安奈德成人体内数据进行验证

CFD-PK model for nasal suspension sprays: Validation with human adult in vivo data for triamcinolone acetonide

Dutta R, Kolanjiyi VA, Walenga RL. et al. International Journal of Pharmaceutics. Volume 665, 15 November 2024, 124660

妊娠期间拉莫三嗪和依法韦仑的PBPK建模：考察对个性化给药和药物相互作用管理的影响

PBPK Modeling of Lamotrigine and Efavirenz during Pregnancy: Implications for Personalized Dosing and Drug-Drug Interaction Management

Costa B, Gouveia MJ, Vale N. Pharmaceutics. Volume 16 Issue 9. 3 September 2024

通过基于生理学的生物药剂学建模了解食物对 omaveloxolone 药代动力学的影响机制

Understanding the mechanisms of food effect on omaveloxolone pharmacokinetics through physiologically based biopharmaceutics modeling

Pepin X, Hynes SM, Zahir H. et al. CPT Pharmacometrics Syst Pharmacol. Volume13, Issue10, October 2024

眼部药物输送的数学模型

Mathematical Models of Ocular Drug Delivery

Sadeghi A, Subrizi A, Del Amo EM. et al. Invest. Ophthal. and Vis. Sci. Volume 65, Issue 11. September 2024

使用PBPK建模和模拟优化利伐沙班速释片仿制药的湿法制粒生产工艺

Optimization of wet granulation process for manufacturing Rivaroxban generic immediate-release tablets using PBPK modeling and simulations

Shiekmydeen J, Tanisha, Sharma S. et al. In Silico Pharmacol Volume 12, article number 77, (2024)

基于生理学的半机制性生物药剂学模型描述二甲双胍的复杂和可饱和吸收：制定缓释制剂溶出标准的依据

A Semi-Mechanistic Physiologically Based Biopharmaceutics Model to Describe Complex and Saturable Absorption of Metformin: Justification of Dissolution Specifications for Extended Release Formulation

Bhattiprolu AK, Kollipara S, Boddu R. et al. AAPS PharmSciTech Volume 25, article number 193, (2024)

新型奥美拉唑缓释口腔崩解片可增强患者依从性：模型引导的制剂开发的应用案例

Novel omeprazole delayed release orally disintegrating tablets for enhanced patient compliance: a case of model informed formulation development

Boddu R, Kolliparaa S, Kambam V. et al. Xenobiotica Volume 54, 2024 - Issue 9

利用计算方法研发针对阴道加德纳菌的药物，以寻求更安全、有效的细菌性阴道病治疗方法

Computational approach for drug discovery against Gardnerella vaginalis in quest for safer and effective treatments for bacterial vaginosis

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