10 Physics-"https:"-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA NLP Consumer Data Review Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

, you will learn how to: Describe the role of consumer studies in the FDA's OTC drug approval process and explain why large volumes of verbatim data present challenges for regulatory review. Identify

FDA Fellowship in Mechanistic Modeling and Clinical Data Analysis of Emerging Drugs

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

and polypharmacy; Learn to process diverse and high-volume data to prepare for modeling; Learn how to adjust model structures/parameters based on calibration data, and evaluate model credibility using

FDA Fellowship Investigating the Impact of Formulation and Manufacturing Factors on the Injectable Sustained-Release Drug Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

generic product development of opioid product. The research also includes investigating issues that are related to the manufacturing process of in-situ forming extended-release dose form. Learning

FDA Fellowship - Mechanistic Modeling and Simulation

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

methods in pharmaceutical quality. Potential research topics include: Machine learning and deep learning methods for process monitoring, anomaly detection, fault diagnosis, and prediction of critical

FDA Fellowship - Applications of Artificial Intelligence, Modeling, and Simulation to Pharmaceutical Manufacturing and Product Characterization

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

to exploration of machine learning and deep learning approaches for tasks such as process monitoring, fault detection, real-time release testing, and the prediction of quality attributes from process data

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 hours ago

. The participant will inoculate relevant biomanufacturing process fluids with bacteria species to determine potential matrix interference and assay limitations. Results from this study will be reported to the cross

FDA Immunogenicity Risk Assessment Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 months ago

activation response, or indirect, by inducing anti-drug antibodies. Product and process impurities can enhance the risks by triggering innate immune receptors that foster the accumulation and activation

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 2 months ago

outcomes and their underlying biological factors in the rat following perinatal exposure. Under the guidance of the mentors, you will engage in many aspects of the research process, including experimental

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

guidance development and regulatory decision-making. This training will provide experience on the process by which product specific guidance is developed and tracked, which will teach skills to enable

FDA Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours ago

the potential to streamline immunogenicity testing by consolidating the multi-tiered process into a single, more efficient method. While the signal-to-noise ratio approach demonstrates clear advantages