19 evolution "https:" "https:" "https:" "https:" "https:" "https:" "Newcastle University" 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 | 1 day 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 | 1 day 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 | 1 day 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 Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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 | 1 day 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 Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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 | 1 day 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 Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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 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 4 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

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

mentorship. This experience will advance your development by providing structured research training applicable to pharmaceutical and regulatory science careers, facilitating professional network development