Manuela Grimstein

10PUBLICATIONS
89CO-AUTHORS
Pharmaceutical delivery technologiesCancer therapy (excl. chemotherapy and radiation therapy)Toxicology (incl. clinical toxicology)Molecular targetsEnvironmental epidemiology
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Publications (10)

|Aug 24, 2026
Application of Model-Informed Approaches in Neuroscience Drug Development and Regulatory Decision-Making.

|Aug 11, 2025
US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting.

Jennifer J Gao, Tatiana M Prowell, Haley Gittleman

|Sep 30, 2024
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.

Tycho Heimbach, Flora Musuamba Tshinanu, Kimberly Raines

|Aug 01, 2024
FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation.

Gulsum E Pamuk, Edwin C Y Chow, Alexei C Ionan

|Jun 14, 2024
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer.

Michael I Barbato, Diana Bradford, Yi Ren

|Feb 21, 2024
US Food and Drug Administration Approval Summary: Elacestrant for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer.

Mirat Shah, Hima Lingam, Xin Gao

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Frequent Collaborators

3 joint publications

Richard Pazdur

2 joint publications

Haley Gittleman

2 joint publications

Shenghui Tang

2 joint publications

Ilynn Bulatao