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

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

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

FDA Computational Toxicology fellowship

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

characteristics, toxicology study parameters, and clinical adverse events. Learning Objectives: Under the guidance of a mentor you will gain experiential, applied knowledge concerning both the SEND data standard

FDA Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

assess product quality attributes of hormones and develop a comprehensive product quality control strategy for fertility hormones. Learning Objectives: During the appointment, you will be trained in

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 1 hour 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 1 hour 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 In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour 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 1 hour 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 Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 27 minutes ago

(DP) plans to re-evaluate these rare safety signals and to determine whether additional regulatory actions are needed. Learning Objectives: Under the guidance of a mentor, you will have the following

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

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