Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications
Journal Title: The AAPS Journal - Year 2008, Vol 10, Issue 1
Abstract
It is widely believed that acceptable bioequivalence studies of drugs with high within-subject pharmacokinetic variability must enroll higher numbers of subjects than studies of drugs with lower variability. We studied the scope of this issue within US generic drug regulatory submissions.
Authors and Affiliations
Barbara M. Davit, Dale P. Conner, Beth Fabian-Fritsch, Sam H. Haidar, Xiaojian Jiang, Devvrat T. Patel, Paul R. H. Seo, Keri Suh, Christina L. Thompson, Lawrence X. Yu
Keywords
Related Articles
- EP ID EP681531
- DOI 10.1208/s12248-008-9015-x
- Views 65
- Downloads 0
Influence of Surface Chemistry on Cytotoxicity and Cellular Uptake of Nanocapsules in Breast Cancer and Phagocytic Cells
The online version of this article (doi:10.1208/s12248-014-9572-0) contains supplementary material, which is available to authorized users.
Cocaine- and amphetamine-regulated transcript peptides play a role in drug abuse and are potential therapeutic targets
Evaluation of USP apparatus 3 for dissolution testing of immediate-release products
We sought to evaluate whether U.S. Pharmacopeia (USP) apparatus 3 can be used as an alternative to USP apparatus 2 for dissolution testing of immediate-release (IR) dosage forms. Highly soluble drugs, metoprolol and rani...
First Characterization of AKB-48 Metabolism, a Novel Synthetic Cannabinoid, Using Human Hepatocytes and High-Resolution Mass Spectrometry
Since the federal authorities scheduled the first synthetic cannabinoids, JWH-018 and JWH-073, new synthetic cannabinoids were robustly marketed. N-(1-Adamantyl)-1-pentylindazole-3-carboxamide (AKB-48), also known as API...
Properties of microcrystalline cellulose and powder cellulose after extrusion/spheronization as studied by fourier transform Raman spectroscopy and environmental scanning electron microscopy
In this study, the effect of powder cellulose (PC) and 2 types of microcrystalline cellulose (MCC 101 and MCC 301) on pellet properties produced by an extrusion/spheronization process was investigated. The different inve...