7 master positions at Center for Drug Evaluation and Research (CDER) in United States

FDA Fellowship in Statistical Methods for New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

regression, principal component analysis, and artificial neural networks — to determine optimal modeling frameworks for high-dimensional in vitro data generated by platforms such as organ-on-a-chip systems and

FDA Fellowship: Evaluation of Novel Endpoints and Innovative Statistical Methodology in Oncology Clinical Trials

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

and principal stratification approaches that explicitly condition on patient subpopulations defined by intercurrent event status, with the goal of producing clinically interpretable estimates

FDA Fellowship in Nasal and Pulmonary Drug Delivery and In Vitro Permeability Research

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

obtained using nasal epithelial models, pulmonary epithelial models, immortalized cell lines, primary cells, air–liquid interface cultures, reconstructed human tissues, microphysiological systems, or other

FDA Fellowship in Generic Opioid Bioequivalence and Safety Research

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

, using immediate-release (IR) oxycodone as the primary model system. Under the guidance of a mentor, you will have the opportunity to 1) characterize fed/fasted bioequivalence (BE) variability across

FDA Fellowship - Evaluating Approaches for Synthetic Data Generation and Evaluation in Regulatory Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 2 months ago

generic drugs. These efforts cover more than just medicines. Research Project: The primary goals of this research fellowship project include: Conducting a systematic literature and tools review on synthetic

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

framework for selecting (primary) endpoint strategies and determining the corresponding statistical analysis plan for non-malignant hematologic diseases in confirmatory trials, starting with the use

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

process Master the bioanalysis of PD biomarker guidance and best practice in industry Understand the scientific considerations in regulatory decision making Through your training, you will be able