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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
to understand the formulations that have been approved under abbreviated new drug applications (ANDAs) and NDAs. The project will also identify and develop in vitro, in vivo, or in silico techniques that may be
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
quantitative data, and synthesize and present findings. This project is critical to our public health mission and the training will prepare the participant for a successful career transition into regulatory
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established
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entail executing experimental designs, conducting laboratory analyses to develop analytical methods comprehensively, and gaining insight into drug development and product quality control. Additionally
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
the guidance of the mentor, the participant will learn state-of-the-art technologies and develop novel technologies for feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
and other generic products with clinical study challenges. Develop/apply PBPK absorption models for oral drug products to support biowaiver and risk-based BE assessment. Innovative approaches
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develop proposals for novel in vitro, in vivo, or in silico techniques that may be capable of determining whether various complexity factors related to generic drug products will impact their bioequivalence
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago
through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant