Sarah Sellers

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Fidaxomicin is a novel macrocyclic antibiotic recently approved by the US Food and Drug Administration for the treatment of Clostridium difficile-associated diarrhea in adults. We reviewed safety data from nonclinical studies and clinical trials (phases 1, 2A, and 3) with fidaxomicin. In nonclinical studies, fidaxomicin was administered orally at(More)
This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I-IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site(More)
Since the development of federal standards for drug approval, the practice of medicine has historically involved the compounding of medications based on a physician’s determination that a US FDA-approved product either did not exist, or could not be used for medical reasons. Today, prescriptions for non-FDA-approved compounded drugs may be driven by(More)
The concept that periodontal disease might influence systemic health is not new. Miller originally published his “focal infection theory” in 1891,1 suggesting that “microorganisms or their waste products obtain entrance of parts of the body adjacent to or remote from the mouth.” Miller and subsequent proponents of the focal infection theory2-4 blamed oral(More)
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