32 information-security "https:" "https:" "https:" "https:" "https:" "UCL" 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 | 3 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 Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

of creatinine effects based on drug exposure and transporter inhibition potency. Acquiring regulatory review skills for evaluating safety, in vitro and pharmacokinetic data in drug applications, including

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

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 Dosage Optimization of Antibody-Drug Conjugates

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation

FDA Dosing of Cancer Drugs in Obesity

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation

FDA Clinical Pharmacology of Novel Modality Biological Products

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS

FDA Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation

FDA Quality Knowledge Management Throughout the Drug Product Lifecycle

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and

FDA Advanced Evaluation of Postmarket Product Quality Reports

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

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation