Showing results (1-10 of 19) with videos related to
Sort By:
Pageof 2
Journal of Food and Drug Analysis|April 29, 2018
A regulatory science viewpoint on botanical-drug interactionsManuela Grimstein, Shiew-Mei HuangPharmaceutics|November 25, 2023
Physiologically Based Pharmacokinetics Modeling in the Neonatal Population-Current Advances, Challenges, and OpportunitiesJean Dinh, Trevor N Johnson, Manuela Grimstein, et al.Journal of Clinical Pharmacology|January 18, 2021
Usage of In Vitro Metabolism Data for Drug-Drug Interaction in Physiologically Based Pharmacokinetic Analysis Submissions to the US Food and Drug AdministrationJieon Lee, Yuching Yang, Xinyuan Zhang, et al.Pharmaceutics|December 23, 2023
Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug PharmacokineticsXinxin Yang, Manuela Grimstein, Michelle Pressly, et al.Journal of Clinical Pharmacology|June 15, 2023
Landscape and Regulatory Perspective on Oncology Drugs in PregnancyRuby Leong, Manuela Grimstein, Peter DeMaria, et al.Journal of Pharmaceutical Sciences|November 3, 2018
Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration's Office of Clinical PharmacologyManuela Grimstein, Yuching Yang, Xinyuan Zhang, et al.Journal of Clinical Pharmacology|July 8, 2016
The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory PerspectivesYuzhuo Pan, Vicky Hsu, Manuela Grimstein, et al.Journal of Clinical Pharmacology|November 18, 2020
Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical PharmacologyXinyuan Zhang, Yuching Yang, Manuela Grimstein, et al.Clinical Pharmacology and Therapeutics|October 16, 2021
Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ DysfunctionJianghong Fan, Yuching Yang, Manuela Grimstein, et al.Clinical Pharmacology and Therapeutics|November 22, 2021
Model-Informed Drug Development Approaches to Assist New Drug Development in the COVID-19 PandemicYe Xiong, Jianghong Fan, Eliford Kitabi, et al.Pageof 2