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

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 24 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 23 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 24 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 | 19 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

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 24 hours ago

to the development of evidence-based guidance for oncology drug dosing in patients with obesity. Gain hands-on experience with data analysis/platforms and knowledge of regulatory science and oncology drug development

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 24 hours ago

drug. Historically, increases in liver enzymes (ALT and AST) has been used to identify subjects with potential DILI during drug development. However, local laboratory normal reference ranges can vary

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 24 hours ago

components for each ORISE fellow (computational, complex in vitro modeling - CiVM and bioanalytical). Computational: The participant will assist in the development of quantitative systems pharmacology models

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

, or sunscreens to support monograph development and updates. Participants will engage in learning opportunities through mentored training sessions focused on OTC drug monograph research methodologies and

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

assumptions is well recognized in pediatric drug development. The FDA has access to data from approximately 1,200 pediatric clinical trials of which data from 600 trials spanning over 300 pediatric development

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 24 hours ago

development for inflammatory bowel disease (IBD). Since the approval of infliximab for Crohn’s disease in 1998, multiple advanced therapies—including ten biologics and four small molecules—have been approved