54 machine-learning-"https:" "https:" "https:" "https:" "https:" "https:" "UCL" positions at Center for Drug Evaluation and Research (CDER)

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

that provide clarity on distinguishing transporter-mediated creatinine elevation from true nephrotoxicity in drug development and regulatory review. Learning Objectives: Educational activities will at least

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

the change in individual level of immunogenicity over time and the change in population level internally and externally Learning Objectives: Through participation in this research opportunities, the you will

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 13 hours ago

multidisciplinary teams including clinical pharmacologists, oncologists, and regulatory reviewers. Contribute to peer-reviewed publications, scientific presentations at conferences. Learning Objectives: During

FDA Fellowship - Strategies to Identify Cases of Prenatal Drug Exposure in FAERS

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours ago

product characteristics on the effectiveness of search strategies. Learning Objectives: You will learn best practices in drug and biological product post-market safety surveillance and receive hands

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours ago

activities related to the research project: participate in data collection from public and proprietary sources, analyze research data, and contribute to presentation/publication of research findings. Learning

FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 1 day ago

for these impurities in various drug products. Learning Objectives: Under the guidance of the mentor, the participant will gain knowledge, expertise and experience in pharmaceutical analysis, specifically in

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 13 hours ago

substitutability evaluation. Learning Objectives: Under the guidance of the mentor, you will gain a comprehensive understanding of the scientific and regulatory challenges that must be considered when establishing

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 13 hours ago

to identify where to direct surveillance efforts. Learning Objectives: Under the guidance of the mentor, you will gain knowledge on the development of an analytical method based upon multiple standards

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

to identify key physiological parameters responsible for altering the PK of LAI in pregnancy and lactation. Learning Objectives: Under the guidance of the mentor(s), the participant will develop the following

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 13 hours ago

), and therapeutic dose selection for IBD. Identify best practices and gaps in dose-selection methodologies to support regulatory decision-making and future pediatric drug development strategies. Learning