32 computer-security "https:" "https:" "https:" "https:" "https:" "Dr" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Review of Pediatric Extrapolation and Dosage Optimization

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

extrapolating safety and efficacy data from adults to pediatrics. Mentor: The mentor for this opportunity is Suryatheja Ananthula (suryatheja.ananthula@fda.hhs.gov ). If you have questions about the nature

FDA Dosage Optimization of Antibody-Drug Conjugates

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

drug-antibody ratios, along with how these characteristics influence therapeutic efficacy and safety profiles. Understand dose-finding methodologies, including dose escalation and expansion strategies

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

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

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

in these populations, to further evaluate the clinical experience during pregnancy and lactation, and to contribute to safety recommendations for drug product labeling. The models could also be used

FDA Clinical Pharmacology of Novel Modality Biological Products

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

of ensuring safety and efficacy of innovative therapeutic modalities. You will investigate pharmacokinetic and pharmacodynamic characteristics of novel biological products through systematic literature reviews

FDA Dosing of Cancer Drugs in Obesity

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

clinical trials to examine dosing, efficacy outcomes, and safety profiles across different body mass index categories, and investigate the relationship between body size (body weight, body mass index, body

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days 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 Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

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

: This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

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

direct interactions with subject matter experts and hand-on training in assessing and evaluating product quality related information using scientific computing tools. Mentor: The mentor

FDA Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

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

. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about