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Articles Related to FDA

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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Addressing the Risk of Product Fraud: A Case Study of the Nigerian Combating Counterfeiting and Sub-Standard Medicines Initiatives

Combating counterfeit medicines requires a new and unique crime scene investigation and forensic science approach. The “crime scene” is both at the production of the counterfeit product anywhere in the world and simultaneously at the packaged product in a consumer’s hand.
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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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Review on Transdermal Drug Delivery Systems

Recently, transdermal drug delivery system (TDDS) has become a more and more important approach to administering drugs. Based on its advantages, which are not achievable by other modes of administration, many researchers are dedicated to the study of it, and have made great progress. Although the skin offers a painless interface for systemic drug delivery, it also presents limitations which are mainly caused by the stratum corneum.
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Pharmacy Compounding Quality Control and Pharmaceutical Development Strategies for Seventeen alpha Hydroxyprogesterone Caproate in Prevention of Preterm Delivery

Seventeen alpha hydroxyprogesterone caproate (17-OHPC) is the only FDA-approved drug labeled for prevention of preterm delivery. This drug is also available as a compounded product from licensed compounding pharmacies. This article reviews the FDA approval history and pharmacy compounding quality control data of 17-OHPC, as well as briefly discusses possible future pharmaceutical development strategies for 17-OHPC.
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Editorial Board Members Related to FDA

Baolin Zhang

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

A. Wallace Hayes

Toxicologist
Emory University
United States

RICHARD G. MOORE

Professor
Department of Obstetrics and Gynecology
Warren Alpert Medical School
Brown University
United States
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