80 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "Newcastle University" positions at Center for Drug Evaluation and Research (CDER) in United States

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

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

concern related to inadequate patient adherence which leads to treatment failures and relapse of chronic disease. Long-acting injectable (LAI) drug products are being developed to overcome inadequate drug

FDA Clinical Pharmacology of Novel Modality Biological Products

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

to evaluate innovative study designs for assessing novel modality clinical pharmacology and research regulatory precedents and contribute to guidance document development for emerging therapeutic modalities

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

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

models (LLMs) to enhance case definition processes by developing a prototype that demonstrates the capability of LLMs to accurately categorize and classify case definitions. The selected fellow will

FDA Dosage Optimization of Antibody-Drug Conjugates

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

products and development programs. Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days 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 Computational Toxicology Fellowship

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

drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: This research project aims to develop quantitative structure-activity relationship

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 23 days ago

drug compounding, including, but not limited to specific bulk drug substances that are used in compounding, advancing FDA's development of the Bulk Lists of substances that can be used in human

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days 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 Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

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

. Serotonin promotes the growth of fetal heart cells while abnormal or blocked serotonin levels can change heart development. Understanding the mechanisms responsible for this association is crucial

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

safety evaluators to discuss findings and their implications for regulatory policy development and review practices. Presenting research findings to the Division of Clinical Pharmacology and other