Top Links

Articles Related to 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.
View complete article: PDF  |  Full-text

Health Food and Traditional Chinese Medicine in China

Like a drug for a purpose of treating or preventing a disease, a health food has to be scientifically evaluation and officially approved before it legally is marketed in China.
View complete article: PDF  |  Full-text

Bioequivalence Study of Two Oral-Capsule Formulations of Omeprazole 20 mg in Combination with Sodium Bicarbonate in Healthy Mexican Adult Volunteers

In Mexico, the immediate-release formulation of omeprazole 20 mg in combination with 1100 mg of sodium bicarbonate (oral capsules) is indicated for patients over 18 years for the treatment of gastritis, reflux, heartburn and the sensation of emptiness caused by the excessive acid production.
View complete article: PDF  |  Full-text

Bioequivalence Study of Two Oral-Capsule Formulations of Pregabalin 300 mg in Healthy Mexican Adult Volunteers

Pregabalin is a ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system. It has anticonvulsant, analgesic, and anxiolytic activity. The bioequivalence of a test formulation was evaluated with respect to its corresponding reference drug formulation of oral pregabalin 300 mg, administered as a capsule. This randomized-sequence, single-dose, single-blind, two-period crossover design under fasting conditions was done on 25 healthy Mexican adult subjects including both genders. There was a seven-day washout period.
View complete article: PDF  |  Full-text

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.
View complete article: PDF  |  Full-text

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.
View complete article: PDF  |  Full-text

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.
View complete article: PDF  |  Full-text


Editorial Board Members Related to 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
Submit Manuscript