25 evolution "https:" "https:" "https:" "https:" "VIB" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

, biomarkers, and model-informed drug development (MIDD) approaches inform final dose selection. Key activities will include reviewing FDA regulatory documents such as Pre-IND communications, End-of-Phase 2 and

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 | about 5 hours ago

the following areas: Development and validation of analytical procedures to assess the qualities of pharmaceutical product. Application of advanced analytical techniques mainly LC-MS in pharmaceutical analysis

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data

FDA Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

BLA submissions and published literature to cooperate in model building, covariate selection, and quantitative tool development. The findings are expected to be applied to innovate clinical trial design

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

the chance to: Gain knowledge about reproductive hormone therapies. Gain knowledge about development of cell-based bioassays. Perform hands-on experiment to learn laboratory techniques including cell

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 | about 5 hours ago

: The development of cell lines for bioassays. This includes cloning of specific genes, monitoring gene expression, selection of clones, single cell cloning, storage retrieval and routine maintenance. Validation

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 | 11 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 Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 5 hours ago

documents and to evaluate how dosing strategies are utilized for oncology drugs in pediatric patients. Findings from this project will inform the development of regulatory policy aimed at refining pediatric

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 5 hours ago

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: Despite tremendous strides in pediatric drug development prompted by the Best Pharmaceuticals for Children Act and

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 5 hours ago

generic drugs. These efforts cover more than just medicines. Research Project: Some biomarkers have been used as multiple roles through one drug development such as a diagnosis biomarker for patient