48 evolution-"https:"-"https:"-"https:"-"https:"-"https:"-"BioData"-"BioData" positions at Center for Drug Evaluation and Research (CDER)

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 2 hours 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 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 2 hours 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

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 hours ago

assumptions is well recognized in pediatric drug development. The FDA has access to data from approximately 1,200 pediatric clinical trials of which data from 600 trials spanning over 300 pediatric development

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 hours ago

to evaluate innovative study designs for assessing novel modality clinical pharmacology and research regulatory precedents and contribute to guidance document development for emerging therapeutic modalities

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 2 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 Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 hours ago

drug. Historically, increases in liver enzymes (ALT and AST) has been used to identify subjects with potential DILI during drug development. However, local laboratory normal reference ranges can vary

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 2 hours ago

components for each ORISE fellow (computational, complex in vitro modeling - CiVM and bioanalytical). Computational: The participant will assist in the development of quantitative systems pharmacology models

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 6 days ago

will contribute to developing internal FDA guidance and supporting peer-reviewed publications on appropriate non-inferiority study design and margin justification in modern ophthalmic drug development

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 hours ago

. Serotonin promotes the growth of fetal heart cells while abnormal or blocked serotonin levels can change heart development. Understanding the mechanisms responsible for this association is crucial

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 hours ago

with multidisciplinary teams to curate large-scale datasets, investigating patterns in toxicological data using statistical methods, contributing to the development of reference compound libraries