19 parallel-processing positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

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

group. The conventional Dunnett’s type I error rate adjustment proposed in 1955 is for superiority tests with normally distributed data. There are statistical concerns about generalizing the procedure

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

research, CDER approved drug products, CDER published guidance including product-specific guidance (PSG), as well as the refinement of processes and infrastructure to analyze and track how research outcomes

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 10 hours ago

for industry guidance, and the quality assessment of drug products for benzene contamination. You will conduct data interpretation and evaluation, gain regulatory process knowledge, conduct experiments, and

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

drug marketing applications received, summarize dosage optimization approaches used by the sponsors during pediatric drug development process, and summarize approaches used by the sponsors when

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 10 hours ago

experiences in regulatory decision-making processes. You will also engage in professional development seminars on scientific writing for regulatory audiences and presentation skills for technical and policy

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 10 hours ago

the potential to streamline immunogenicity testing by consolidating the multi-tiered process into a single, more efficient method. While the signal-to-noise ratio approach demonstrates clear advantages

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

designs in various patient populations and understand the regulatory implications of dosing recommendations. Understanding of FDA's drug review process, particularly regarding clinical pharmacology

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

review process. Learning Objectives: Under the guidance of the mentor(s),you will develop the following skills during the fellowship; (1) data collection and analysis, (2) clinical pharmacology and

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 10 hours ago

. The goal of these quantitative systems pharmacology models is to define a data processing pathway and model validation method that will be used in various areas with particular emphasis on drug polypharmacy