72 machine-learning "https:" "https:" "https:" "https:" "https:" "https:" "Imperial College London" 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 17 hours ago

generic products to support bioequivalence and product development. Learning Objectives: Under the guidance of the mentor, the participant will gain a comprehensive understanding of the scientific and

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 | about 17 hours 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 Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 17 hours 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 17 hours 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 Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 17 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

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 17 hours ago

dissemination. The participant will regularly present and discuss findings at internal meetings that will include members of NCTR and CDER staff. Learning Objectives: As a participant, you will learn numerous

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 17 hours 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 In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days 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 17 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 Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 25 days ago

. Learning Objectives: Under the guidance of the mentor, you will gain comprehensive experience in regulatory biostatistics through hands-on analysis of clinical trial data from FDA submissions in