40 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "https:" "University of Kent" Fellowship positions at Center for Drug Evaluation and Research (CDER) in United States

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: This research project aims to develop quantitative structure-activity relationship

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

development have been restricted to juvenile animal studies for the past 20 years. The FDA program to reduce, refine and replace animal studies has stimulated an important discussion about both increasing

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 14 days ago

drug compounding, including, but not limited to specific bulk drug substances that are used in compounding, advancing FDA's development of the Bulk Lists of substances that can be used in human

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

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

. Serotonin promotes the growth of fetal heart cells while abnormal or blocked serotonin levels can change heart development. Understanding the mechanisms responsible for this association is crucial

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 12 hours ago

of pregnancy and lactation postmarketing requirement studies. Pregnant and lactating women have historically been excluded from drug development trials. Therefore, at the time of new drug/biologic approval

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 12 hours ago

, additional research is needed to establish its utility for quantitatively characterizing ADA time-course profiles compared to traditional tiered approaches. In our previous research, we developed a

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

analytical tools Learning research database design principles and data management best practices Contributing to development of evidence-based recommendations for regulatory policy enhancement Participating in

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 12 hours ago

molecular attributes and biological responses. This project proposes to develop an AI/ML-integrated translational framework that associates analytical quality parameters to PK, immunogenicity, and safety

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 26 days ago

will contribute to developing internal FDA guidance and supporting peer-reviewed publications on appropriate non-inferiority study design and margin justification in modern ophthalmic drug development