67 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" positions at Center for Drug Evaluation and Research (CDER)

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 | about 14 hours 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 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 14 hours ago

analyze the impact of these changes on regulatory decision-making. During the project, you will help: Collect comprehensive data on dosage optimization strategies from recently approved oncology New Drug

FDA Review of Pediatric Extrapolation and Dosage Optimization

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

FDA Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

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

mathematical ADA model to provide quantitative immunogenicity assessment for therapeutic proteins. This model was constructed using antibody titer data from subjects across 10 clinical trials, with ADA time

FDA Clinical Pharmacology / Model Informed Drug Development

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

are made for nucleotide-based therapeutics—such as antisense oligonucleotides, siRNA, and mRNA—intended for neurological diseases. The you will help investigate how safety margins, nonclinical data

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 14 hours ago

considering all the data, not just subgroup specific data. A BHM assumes exchangeability in treatment effects across subgroups after adjusting for effect modifiers and other relevant covariates. In this project

FDA Dosage Optimization of Antibody-Drug Conjugates

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

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: The project will collect data on the characteristics and exposure-response relationships for currently approved

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

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

, there are only animal data to inform the safety in pregnant and lactating women. Pregnancy safety and lactation data are collected predominantly in the post approval setting. The 2007 FDA Amendments Act gave FDA

FDA Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 15 hours ago

-market surveillance systems suffer from underreporting bias, confounding by indication, and unclear temporal relationships. Meta-analyses based on pooled study-level or subject-level clinical data play a

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

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

related to pharmaceutical quality, lifecycle management of drug products, and data analytics and modeling to support regulatory decision making. The participant will acquire the above mentioned through