Lv11
38 积分 2024-05-15 加入
Four Decades of History & Evolution of Clinical Pharmacology at US Food and Drug Administration (FDA)—Part II: Dose Individualization and Approvability Evidence
5小时前
待确认
Design, simulate, refine: simulation-guided clinical trials for accelerated drug development
7天前
已完结
Pediatric Extrapolation in Neuropsychiatric Drug Development: Leveraging Pharmacokinetic and Pharmacodynamic Strategies to Facilitate FDA Approvals
1个月前
已完结
Application of Bayesian statistics to support approval of intravenous belimumab in children with systemic lupus erythematosus in the United States
1个月前
已完结
Impact of Model‐Informed Drug Development on Drug Development Cycle Times and Clinical Trial Cost
2个月前
已完结
Predicting pharmacodynamic effects through early drug discovery with artificial intelligence-physiologically based pharmacokinetic (AI-PBPK) modelling
3个月前
已关闭
Beyond MABEL: An Integrative Approach to First in Human Dose Selection of Immunomodulators by the Health and Environmental Sciences Institute (HESI) Immuno‐Safety Technical Committee (ITC)
4个月前
已完结
Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology
4个月前
已完结
Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression
9个月前
已完结
Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology
10个月前
已完结
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