7 coding-"https:" "https:" "https:" "https:" "https:" "https:" "I.E" "Helmholtz Zentrum Geesthacht" positions at Center for Drug Evaluation and Research (CDER)

FDA Postdoctoral Fellowship / Research Fellowship: 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 | 4 days 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 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 | 21 days 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 Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

are at least two PBPK maternal models to predict the PK profile of LAI drug products (i.e., cabotegravir, aripiprazole) in pregnant and lactating people. These PBPK models will help predict drug exposure during

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

significantly (i.e., up to 2-fold) because they can be influenced by prevalent subclinical liver disease in the local population.  Lack of uniform absolute values for ALT upper limit of normal (ULN) can result in

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

(i.e. same study protocol for both regions). Define the characteristics of the study: e.g. study method (pregnancy registry, claims database study, descriptive pregnancy safety study) is the intent

FDA Bayesian Inference for Safety Signal Detection

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

Science (CDS) staff, you will develop comprehensive expertise in Bayesian statistical methods for safety signal detection. Training will include structured learning through selected reading, guided coding

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

) absorption models, in vitro - in vivo correlations and pharmacokinetic/pharmacodynamic (PK/PD) modeling) including biowaivers. Modeling and simulation to reduce/replace in vivo BE studies (i.e., in vivo PK BE