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British Journal of Clinical Pharmacology|June 23, 2016
Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategyMahesh N Samtani, Partha Nandy, Paulien Ravenstijn, et al.
Alzheimer'S & Dementia (New York, N. Y.)|June 2, 2018
Alzheimer's disease assessment scale-cognitive 11-item progression model in mild-to-moderate Alzheimer's disease trials of bapineuzumabMahesh N Samtani, Steven X Xu, Alberto Russu, et al.
Alzheimer'S & Dementia (New York, N. Y.)|June 2, 2018
Alzheimer's disease progression model using disability assessment for dementia scores from bapineuzumab trialsSteven X Xu, Mahesh N Samtani, Alberto Russu, et al.
Journal of Alzheimer'S Disease : JAD|May 11, 2016
Biomarker Exposure-Response Analysis in Mild-To-Moderate Alzheimer's Disease Trials of BapineuzumabAlberto Russu, Mahesh N Samtani, Steven Xu, et al.
American Heart Journal|May 28, 2019
Rivaroxaban, a direct Factor Xa inhibitor, versus acetylsalicylic acid as thromboprophylaxis in children post-Fontan procedure: Rationale and design of a prospective, randomized trial (the UNIVERSE study)Liza Miriam Pina, Xiangwen Dong, Liping Zhang, et al.
Clinical Pharmacology and Therapeutics|August 22, 2025
Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial FibrillationWangda Zhou, Emily Bozenhardt, Gregory E Alexander, et al.
Targeted Oncology|May 7, 2025
Teclistamab Dosing in Responders: Modeling and Simulation Results from the MajesTEC-1 Study in Relapsed/Refractory Multiple MyelomaYue Guo, Jin Niu, Natalia A Quijano Cardé, et al.
Clinical Pharmacology and Therapeutics|July 24, 2025
Recommended Phase II Doses of Talquetamab in Patients With Relapsed/Refractory Multiple Myeloma From MonumenTAL-1: Clinical Pharmacology ResultsJue Gong, Jie Zhou, Dongfen Yuan, et al.
Clinical Pharmacology and Therapeutics|March 23, 2024
Considerations for Industry-Preparing for the FDA Model-Informed Drug Development (MIDD) Paired Meeting ProgramGerald R Galluppi, Malidi Ahamadi, Souvik Bhattacharya, et al.
Targeted Oncology|March 26, 2026
Revised Recommendations for Restarting Teclistamab Following Dose Delays: Insights from the MajesTEC-1 Study on Clinical Safety, and from Simulated Pharmacokinetics and Cytokine DynamicsNatalia A Quijano Cardé, Jin Niu, Yue Guo, et al.
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