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

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 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

variety of advanced analytical and bioanalytical assays from method development to experimental or test sample analysis including the process of method validation. Learning Objectives: Computational

FDA Developmental Safety Fellowship

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

development have been restricted to juvenile animal studies for the past 20 years. The FDA program to reduce, refine and replace animal studies has stimulated an important discussion about both increasing

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

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

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

interpretation of clinical/model-based PK data in the context of dosing and safety; 3) Collaborate with PBPK experts both within and outside the FDA; 4) Gain an understanding of the drug regulatory review process

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 2 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 2 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 Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

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

and streamline clinical development program, contributing to precision medicine. Learning Objectives: The project provides training opportunities to understand quantitative approaches that can be

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

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

meetings and project meetings, to better understand pediatric drug development and clinical pharmacology concepts. The fellow will be able to observe, but not participate in, the regulatory review process