14 Physics-"https:"-"https:" 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 22 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 22 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 22 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 21 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 Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process

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 21 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 Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 3 months ago

to support regulatory activities. The participant will also learn to characterize physical characteristics of aerosol spray products using instrumentation such as laser diffraction, high-speed imaging, cascade