33 development-"https:"-"https:"-"https:" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

, biomarkers, and model-informed drug development (MIDD) approaches inform final dose selection. Key activities will include reviewing FDA regulatory documents such as Pre-IND communications, End-of-Phase 2 and

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 14 days ago

the guidance of the mentor, you will learn state-of-the-art technologies and develop novel technologies for feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal antibody

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 | 14 days ago

). The project is to develop liquid chromatography-mass spectrometry (LC-MS) methods for the analysis of nitrosamine impurities in drug products and apply the developed and validated methods to screen

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data

FDA Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

BLA submissions and published literature to cooperate in model building, covariate selection, and quantitative tool development. The findings are expected to be applied to innovate clinical trial design

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

generic drugs. This work covers more than just medicines. Research Project: The fellow will participate in a research project to develop optimal cell-based gene reporter potency assays for FSH, LH, and hCG

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 | 14 days ago

generic drugs. This effort covers more than just medicines. Research Project: You will cooperate in developing bioassays to assess the potency of fertility hormones. This will include follicle stimulating

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

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

analyses in clinical trial submissions to the U.S. Food and Drug Administration (FDA). The project focuses on developing a structured framework to guide statistical reviewers in evaluating mediation analyses

FDA Opportunity - Web-based Visualization Tool for NDA/BLA Submission Info

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project:  If selected, you will join a project to develop a web-based visualization platform for NDA/BLA submission

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 14 days ago

patients is challenging. The objective of this project is to develop a pediatric oncology database by collecting data from pediatric study protocols, regulatory marketing applications and FDA review