Dragos Roman
Center for Drug Evaluation and Research
2 Papers
12 Citations
Dragos Roman is an academic researcher from Center for Drug Evaluation and Research. The author has contributed to research in topics: Hypoparathyroidism & Hypercalciuria. The author has an hindex of 2, co-authored 2 publications.
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Papers
Use of a Systems Pharmacology Model Based Approach Toward Dose Optimization of Parathyroid Hormone Therapy in Hypoparathyroidism.
Manoj Khurana,Immo Zadezensky,Naomi Lowy,Dragos Roman,Jean‐Marc Guettier,Liang Li,Jeffry Florian,Chandrahas G. Sahajwalla,Vikram Sinha,Nitin Mehrotra +9 more
TL;DR: An application of a quantitative systems pharmacology (QSP) model to support a regulatory decision, specifically in assessing the adequacy of the proposed dosing regimen of Natpara to control hypocalcemia in patients with hypoparathyroidism, fulfilled the information gap to support recommendations of this postmarketing trial.
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Sarcopenia: what's in a name?
TL;DR: Sarcopenia illustrates the impact that constantly advancing medical knowledge has on disease definition and taxonomy and shows how a lack of clarity or consensus in a medical definition can affect drug innovation: in particular, how such a lack can influence academic research, drug development, and regulatory expectations.