25 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Newcastle University" uni jobs at Center for Drug Evaluation and Research (CDER)

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

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

adherence and associated treatment failure. Given the paucity of data in pregnancy and lactation, model-based approaches (such as physiologically-based pharmacokinetic (PBPK) modeling) are being employed

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

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

. The research will analyze published literature, post-marketing data, and simulated-use studies to evaluate contamination pathways, packaging integrity, consumer misuse patterns, and labeling practices. You will

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 1 day ago

cannisters, including particle size distribution, droplet evaporation, movement, and deposition. New methodology and data will be generated on the performance of aerosol sprays to support FDA regulatory

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

website for information about the valid immigration statuses that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

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

project and under the guidance of the mentor, you will contribute with: Collecting comprehensive data on oncology drugs known to inhibit renal transporters (particularly OCT2, MATE1, and MATE2-K), including

FDA Dosing of Cancer Drugs in Obesity

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

-making regarding appropriate dosing, clinical trial design, and labeling of oncology drugs for patients with obesity. During the appointment you will: Engage in comprehensive data analysis of oncology

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

. 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

FDA Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

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

. Mitigations (rules that may change an incorrect response in a study to a correct response) and participant verbatim information requiring qualitative analysis, complicate consumer study review, making review

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

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

methods informs OTC drug monographs and labeling. Scientific writing and data analysis/synthesis: Developing a peer-reviewed manuscript for a regulatory science journal with data tables and visual

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

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

website for information about the valid immigration statuses that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to