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Articles Related to US Food and Drug Administration

Evaluating the Effect of Oprelvekin on Cardiac Repolarization in Subjects with Chemotherapy-Induced Thrombocytopenia: An Observational Chart Review of a Phase 2 Clinical Trial in Laredo, Texas

This study tested for the cardiac effects of Oprelvekin, recombinant human interleukin-11, a thrombopoietic growth factor, in patients afflicted with chemotherapy-induced thrombocytopenia (platelet count<50,000 cells/ul). Chart-reviews of patients fulfilling the inclusion criteria of: 18-75 yrs of age, non-myeloid malignancy, with adequate hematologic, hepatic and renal parameters and normal electrocardiograms that were enrolled in this phase 2 trial were analyzed. Patients of child-bearing potential agreed to be on a reliable form of birth control for the duration of the study. Results on 4 patients suggest that Oprelvekin does not cause atrial nor ventricular arrhythmia, a rare severe cardiac side effect, in treating patients with chemotherapy-induced thrombocytopenia.
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Orally Disintegrating Tablets: A Short Review

This article summarizes the advantages of orally disintegrating tablets (ODTs) as well as critical issues during evaluation of ODTs such as bioequivalence and challenges and limitations of ODTs and finally present and the future of ODTs. ODTs have received everincreasing demand and the field has become a rapidly growing area in the pharmaceutical industry.
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Pharmacokinetics, Biotransformation, Distribution and Excretion of Empagliflozin, a Sodium-Glucose Co-Transporter (SGLT 2) Inhibitor, in Mice, Rats, and Dogs

The metabolism, pharmacokinetics, excretion and distribution of a sodium-glucose co-transporter (SGLT 2) inhibitor, empagliflozin, were studied in mice, rats and beagle dogs following a single oral or intravenous administration of [14C]-empagliflozin. Empagliflozin was well absorbed in all species after oral administration.
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Editorial Board Members Related to US Food and Drug Administration

Baolin Zhang

Division of Therapeutic Proteins
Office of Biotechnology Products
FDA/Center for Drug Evaluation and Research
United States

RICHARD K. GILROY

Professor of Medicine
Medical Director of Liver Transplantation
Department of Gastroenterology and Hepatology
University of Kansas Medical Center
United States
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