63 evolution "https:" "https:" "https:" "https:" "https:" "https:" "Aix Marseille Université " positions at Center for Drug Evaluation and Research (CDER)

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

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

mentorship. This experience will advance your development by providing structured research training applicable to pharmaceutical and regulatory science careers, facilitating professional network development

FDA Dosage Optimization of Antibody-Drug Conjugates

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

products and development programs. Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 41 minutes 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 Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 41 minutes ago

to drugs in the breastfed infant. This project focuses on development of PBPK models for LAI drug products (e.g., antiretroviral drugs and psychiatric drug products). The anticipated project outcomes

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour 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 Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 18 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 Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 42 minutes 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

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

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

generic drugs. This effort covers more than just medicines. Research Project: With the development of Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance, the Office of Quality

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour 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 Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

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

clinical data from multiple sources within FDA's information systems. You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug