80 data-"https:" "https:" "https:" "https:" "https:" "https:" "Eindhoven University of Technology (TU" positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 3 hours ago

a multidisciplinary team to develop frameworks for standardizing and combining subject-level data from hundreds of clinical trials, including over 20 completed cardiovascular outcome trials. You will

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 3 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 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 3 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 Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 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 3 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 3 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 3 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 3 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 Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 hours ago

compounding. Learning Objectives: Under the guidance of the mentor, you will gain skills and confidence in making scientific presentations; learn how to collect and compile clinical information; and learn

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 3 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