63 computational-physics "https:" "https:" "https:" "https:" "Caltech" positions at Center for Drug Evaluation and Research (CDER)

FDA Computational Toxicology fellowship

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

of funds. Level of Participation: The appointment is full time. Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only. This program, administered

FDA Computational Toxicology Fellowship

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

. Learning Objectives: Under the guidance of a mentor, the participant will learn about the development of computational models for regulatory use. Research and training activities may include: Learning

FDA Computational Biology and Pharmacology Fellowship

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

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 2 hours ago

to support regulatory activities. The participant will also learn to characterize physical characteristics of aerosol spray products using instrumentation such as laser diffraction, high-speed imaging, cascade

FDA Product Specific Guidance and Research Fellowship

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

how the impact of outcomes from a scientific research program can be maximized to support future decision making. Learning Objectives: You will gain insight into the FDA's Office of Generic Drugs, and

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 2 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 2 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

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

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

public health mission in order to have a future of highly trained regulatory scientists in clinical pharmacology. Students and fellows can observe, but not participate in, the regulatory review process

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 2 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 Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

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

process Master the bioanalysis of PD biomarker guidance and best practice in industry Understand the scientific considerations in regulatory decision making Through your training, you will be able