32 computational-physics "https:" "https:" "https:" "https:" "Caltech" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

to deliver faster and more accurate results along with establishment of a detection tool. Learning Objectives: Under the guidance of the mentor(s), you will be able to explore CDER post market report program

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 23 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 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 23 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 22 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 23 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 23 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 23 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 22 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 Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 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