Manuela Grimstein

Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the U.S. Food and Drug Administration’s Office of Clinical Pharmacology

Manuela Grimstein, Yuching Yang, Xinyuan Zhang et al. · Journal of Pharmaceutical Sciences · 2018 · 308 citations

Pharmacy, Pharmacokinetics, Pharmacology +17

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 Pharmacology

Xinyuan Zhang, Yuching Yang, Manuela Grimstein et al. · The Journal of Clinical Pharmacology · 2020 · 179 citations

Pharmacy, Pharmacokinetics, Pharmacology +15

US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative, <i>ESR1</i>-Mutated Advanced or Metastatic Breast Cancer

Mirat Shah, Hima Lingam, Xin Gao et al. · Journal of Clinical Oncology · 2024 · 38 citations · Full text

Medicine, Oncology, Pharmacology +17

FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Deepti Telaraja, Yvette L. Kasamon, Justin S. Collazo et al. · Clinical Cancer Research · 2023 · 30 citations · Full text

Medicine, Oncology, Pharmacology +16

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 Dysfunction

Jianghong Fan, Yuching Yang, Manuela Grimstein et al. · Clinical Pharmacology & Therapeutics · 2021 · 23 citations

Pharmacy, Pharmacokinetics, Pharmacology +15