Chemical Potency and Degradation Products of Medications Stored Over 550 Earth Days at the International Space Station
Journal Title: The AAPS Journal - Year 2016, Vol 18, Issue 1
Abstract
The online version of this article (doi:10.1208/s12248-015-9834-5) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Virginia E. Wotring
Regulatory Administrative Databases in FDA's Center for Biologics Evaluation and Research: Convergence Toward a Unified Database
Regulatory administrative database systems within the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) are essential to supporting its core mission, as a regulatory agency. Such sy...
Pharmacokinetics in mice implanted with xenografted tumors after intravenous administration of tasidotin (ILX651) or its carboxylate metabolite
The pharmacokinetics of tasidotin (ILX651), a depsipeptide currently in phase II for the treatment of advanced solid tumors, and tasidotin-C-carboxylate, the main metabolite, were characterized in male nude mice implante...
G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS
The Biopharmaceutics Classification System (BCS) has become widely accepted today in the academic, industrial, and regulatory world. While the initial application of the BCS was to regulatory science bioequivalence (BE)...
Glucocorticoid Receptor-Mediated Transcriptional Regulation of N-acetyltransferase 1 Gene Through Distal Promoter
Human arylamine N-acetyltransferase 1, (HUMAN)NAT1, is a phase II xenobiotic-metabolizing enzyme that plays an important role in drug and carcinogen biotransformation and cancer development. Its gene expression has been...
Advanced pharmacokinetic models based on organ clearance, circulatory, and fractal concepts
Three advanced models of pharmacokinetics are described. In the first class are physiologically based pharmacokinetic models based on in vitro data on transport and metabolism. The information is translated as transporte...