日期 影响因子
日期:
2020 年 — 2026 年
2020
2021
2022
2023
2024
2025
2026
影响因子:
–

Emerging perspectives on leveraging physiologically based biopharmaceutics modeling (PBBM) for BCS class III biowaivers: A webinar summary

利用生理学生物药剂学模型（PBBM）申请BCS III类生物豁免的新视角：网络研讨会总结

期刊:Journal of Pharmaceutical Sciences
影响因子:3.8
doi:10.1016/j.xphs.2025.104030
Fang, Lanyan; Veerasingham, Shereeni; Xu, Yunming; Garcia-Arieta, Alfredo; Kollipara, Sivacharan; Kanagasabapathy, Yuvaneshwari; Ahmed, Tausif; Martins, Frederico Severino; Suarez-Sharp, Sandra
发表日期：2025
文献求助 收藏

The Development of an Age-Appropriate Fixed Dose Combination for Tuberculosis Using Physiologically-Based Pharmacokinetic Modeling (PBBM) and Risk Assessment

利用生理药代动力学模型（PBBM）和风险评估开发适合不同年龄段的结核病固定剂量复方制剂

期刊:Pharmaceutics
影响因子:5.5
doi:10.3390/pharmaceutics16121587
Pepin, Xavier J H; Johansson Soares Medeiros, Juliana; Deris Prado, Livia; Suarez Sharp, Sandra
发表日期：2024
文献求助 收藏

Physiologically Based Biopharmaceutics Modeling (PBBM): Best Practices for Drug Product Quality, Regulatory and Industry Perspectives: 2023 Workshop Summary Report

基于生理的生物药剂学建模（PBBM）：药品质量、监管和行业展望的最佳实践：2023 年研讨会总结报告

期刊:Molecular Pharmaceutics
影响因子:4.5
doi:10.1021/acs.molpharmaceut.4c00202
Mackie, Claire; Arora, Sumit; Seo, Paul; Moody, Rebecca; Rege, Bhagwant; Pepin, Xavier; Heimbach, Tycho; Tannergren, Christer; Mitra, Amitava; Suarez-Sharp, Sandra; Borges, Luiza Novaes; Kijima, Shinichi; Kotzagiorgis, Evangelos; Malamatari, Maria; Veerasingham, Shereeni; Polli, James E; Rullo, Gregory
发表日期：2024
文献求助 收藏

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

通过基于生理的生物药剂学模型，了解食物对奥马维洛酮药代动力学的影响机制。

期刊:Cpt-Pharmacometrics & Systems Pharmacology
影响因子:3
doi:10.1002/psp4.13221
Pepin, Xavier J H; Hynes, Scott M; Zahir, Hamim; Walker, Deborah; Semmens, Lois Q; Suarez-Sharp, Sandra
发表日期：2024
文献求助 收藏

Regulatory Perspectives on Strength-Dependent Dissolution Profiles and Biowaiver Approaches for Immediate Release (IR) Oral Tablets in New Drug Applications

新药申请中速释（IR）口服片剂的强度依赖性溶出曲线和生物豁免方法的监管视角

期刊:AAPS Journal
影响因子:3.7
doi:10.1208/s12248-016-9893-2
Suarez-Sharp, Sandra; Delvadia, Poonam R; Dorantes, Angelica; Duan, John; Externbrink, Anna; Gao, Zongming; Ghosh, Tapash; Miksinski, Sarah Pope; Seo, Paul
发表日期：2016
文献求助 收藏

CDER risk assessment exercise to evaluate potential risks from the use of nanomaterials in drug products

CDER风险评估活动旨在评估在药品中使用纳米材料可能带来的风险

期刊:AAPS Journal
影响因子:3.7
doi:10.1208/s12248-013-9466-6
Cruz, Celia N; Tyner, Katherine M; Velazquez, Lydia; Hyams, Kenneth C; Jacobs, Abigail; Shaw, Arthur B; Jiang, Wenlei; Lionberger, Robert; Hinderling, Peter; Kong, Yoon; Brown, Paul C; Ghosh, Tapash; Strasinger, Caroline; Suarez-Sharp, Sandra; Henry, Don; Van Uitert, Maat; Sadrieh, Nakissa; Morefield, Elaine
发表日期：2013
文献求助 收藏