Manuela Grimstein
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View article: Supplementary Table S1 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation
Supplementary Table S1 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation Open
Specific dose modification strategies for concomitant use of asciminib with other drug products
View article: Supplementary Table S4 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation
Supplementary Table S4 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation Open
The list of preferred terms included in grouped terms used for safety analysis in X2101 trial
View article: Data from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation
Data from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation Open
On October 29, 2021, FDA granted accelerated approval to asciminib (SCEMBLIX; Novartis), a tyrosine kinase inhibitor (TKI), for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chr…
View article: Supplementary Table S2 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation
Supplementary Table S2 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation Open
The list of preferred terms included in grouped terms used for safety analysis in ASCEMBL
View article: Supplementary Table S3 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation
Supplementary Table S3 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation Open
Select laboratory abnormalities (≥ 10%) that worsened from baseline in patients with Ph + CML in CP, previously treated with two or more tyrosine kinase inhibitors in ASCEMBL
View article: Supplementary Table S5 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation
Supplementary Table S5 from FDA Approval Summary: Asciminib for Ph<sup>+</sup> CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the <i>T315I</i> Mutation Open
Select laboratory abnormalities (≥ 10%) that worsened from baseline in patients with Ph + CML in CP with the T315I mutation in X2101 trial
View article: PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report Open
The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein. Day 2 covered PBBM …
View article: FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer
FDA Approval Summary: Repotrectinib for Locally Advanced or Metastatic ROS1-Positive Non–Small Cell Lung Cancer Open
On November 15, 2023, the U.S. Food and Drug Administration (FDA) granted traditional approval to repotrectinib (Augtyro, Bristol Myers Squibb Corporation) for the treatment of adult patients with locally advanced or metastatic receptor ty…
View article: Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics
Utility of Physiologically Based Pharmacokinetic Modeling to Investigate the Impact of Physiological Changes of Pregnancy and Cancer on Oncology Drug Pharmacokinetics Open
Background: The treatment of cancer during pregnancy remains challenging with knowledge gaps in drug dosage, safety, and efficacy due to the under-representation of this population in clinical trials. Our aim was to investigate physiologic…
View article: Physiologically Based Pharmacokinetics Modeling in the Neonatal Population—Current Advances, Challenges, and Opportunities
Physiologically Based Pharmacokinetics Modeling in the Neonatal Population—Current Advances, Challenges, and Opportunities Open
Physiologically based pharmacokinetic (PBPK) modeling is an approach to predicting drug pharmacokinetics, using knowledge of the human physiology involved and drug physiochemical properties. This approach is useful when predicting drug pha…
View article: FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
FDA Approval Summary: Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma Open
In January 2023, the FDA granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton tyrosine kin…
View article: Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy
Landscape and Regulatory Perspective on Oncology Drugs in Pregnancy Open
Cancers affecting pregnant women include breast cancer, melanoma, thyroid cancer, cervical cancer, lymphomas, and leukemias. The medical management of cancer during pregnancy with molecularly targeted oncology drugs remains quite challengi…
View article: Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic
Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic Open
Leveraging limited clinical and nonclinical data through modeling approaches facilitates new drug development and regulatory decision making amid the coronavirus disease 2019 (COVID‐19) pandemic. Model‐informed drug development (MIDD) is a…
View article: Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development
Characterization of Plasma Protein Alterations in Pregnant and Postpartum Individuals Living With HIV to Support Physiologically-Based Pharmacokinetic Model Development Open
Background: Alterations in plasma protein concentrations in pregnant and postpartum individuals can influence antiretroviral (ARV) pharmacokinetics. Physiologically-based pharmacokinetic (PBPK) models can serve to inform drug dosing decisi…
View article: FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations
FDA Approval Summary: Capmatinib and Tepotinib for the Treatment of Metastatic NSCLC Harboring MET Exon 14 Skipping Mutations or Alterations Open
The FDA approved capmatinib and tepotinib on May 6, 2020, and February 3, 2021, respectively. Capmatinib is indicated for patients with metastatic non–small cell lung cancer (mNSCLC) whose tumors have a mutation leading to mesenchymal–epit…
View article: Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations Open
A critical step to evaluate the potential in vivo antiviral activity of a drug is to connect the in vivo exposure to its in vitro antiviral activity. The Anti–SARS‐CoV‐2 Repurposing Drug Database is a database that includes both in vitro a…
View article: A regulatory science viewpoint on botanical–drug interactions
A regulatory science viewpoint on botanical–drug interactions Open
There is a continued predisposition of concurrent use of drugs and botanical products. Consumers often self-administer botanical products without informing their health care providers. The perceived safety of botanical products with lack o…
View article: The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives
The Application of Physiologically Based Pharmacokinetic Modeling to Predict the Role of Drug Transporters: Scientific and Regulatory Perspectives Open
Transporters play an important role in drug absorption, disposition, and drug action. The evaluation of drug transporters requires a comprehensive understanding of transporter biology and pharmacology. Physiologically based pharmacokinetic…