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

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in vitro, in

FDA Fellowship - Digital Health Technologies in Drug Development: Endpoint Analysis, Regulatory Guidance Comparison, and Systematic Literature Review

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

drug development by examining how digitally-derived endpoints are designed, validated, and implemented across clinical trials, therapeutic areas, and patient populations through systematic review

FDA CDER Regulatory Science Fellowship

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

team and may help in designing and developing visualizations and dashboards. Results of the research may inform updates to data considerations for internal regulatory science databases. Additionally, you

FDA Fellowship - Orange Book NDA and ANDA Parenteral Combination Drug Product

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

. Learn various aspects of the Orange Book publication information to support miscellaneous projects as directed by the mentor or other designated staff members. Mentor: The mentor for this opportunity is

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

advanced in silico prediction algorithms, analyzing machine learning approaches for toxicity pattern recognition, and participating in developing standardized computational frameworks for regulatory

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

dynamics models to develop new BE methods for locally acting drug products administered via non-oral routes. Population PK modeling to support more effective in vivo study designs and methods for evaluating

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

vivo, and/or in silico study designs for establishing bioequivalence with these products. Mentor: The mentor for this opportunity is Dongmei Lu ([email protected] ). If you have questions about the

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 11 hours ago

-course profiles characterized through a two-component semi-mechanistic model that captured the characteristic double-peak pattern of antibody responses. We also explored relationships between antibody