Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window Poster Mechanistic Modeling Guides Bispecific Antibody Design and Target Selection for Maximizing Therapeutic Window Therapeutic antibodies have shown promise in treating diseases such as cancer, but selectivity remains a…CertaraMarch 28, 2025
QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy Case Study QSP Modeling Optimizes FIH Dose Selection for Multiple Myeloma Therapy Multiple myeloma, the second most common blood cancer, affects an estimated 160,000 individuals annually worldwide…CertaraMarch 25, 2025
Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study Publication Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…CertaraMarch 20, 2025
Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach Publication Postmarketing Assessment of Antibody–Drug Conjugates: Proof-of-Concept Using Model-Based Meta-Analysis and a Clinical Utility Index Approach This study explores a model-based meta-analysis (MBMA) and a clinical utility index (CUI) approach to…CertaraMarch 4, 2025
Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe White Paper Rare Oncology Product Launch Playbook: Universal Strategies for Success in the U.S. and Europe Lorem ipsum dolor sit amet consectetur. At venenatis urna sapien ut lorem enim. Morbi lectus…CertaraFebruary 28, 2025
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies Publication Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…CertaraFebruary 6, 2025
Understanding Variability in CAR-T Cell Therapy Kinetics Publication Understanding Variability in CAR-T Cell Therapy Kinetics Axicabtagene ciloleucel (axi-cel), a CAR-T cell therapy for relapsed and refractory non-Hodgkin’s lymphoma (NHL), demonstrates…CertaraJanuary 23, 2025
Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma Poster Simultaneous Population PKPD Analysis of Belantamab Mafodotin, Soluble BCMA, and Serum M-Protein in Subjects With Relapsed/Refractory Multiple Myeloma CertaraNovember 22, 2024
A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model Poster A Pharmacokinetic Analysis of Drug Concentration Using a Novel Deep Learning Model CertaraNovember 22, 2024
Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies Poster Model-Informed Drug Development Framework for the Development and Dose Optimization of Targeted Radiation Therapies CertaraNovember 22, 2024