International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences
Journal Title: The AAPS Journal - Year 2015, Vol 17, Issue 3
Abstract
The online version of this article (doi:10.1208/s12248-015-9733-9) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Dongmei Lu, Sau L. Lee, Robert A. Lionberger, Stephanie Choi, Wallace Adams, Hoainhon N. Caramenico, Badrul A. Chowdhury, Dale P. Conner, Rohit Katial, Susan Limb, John R. Peters, Lawrence Yu, Sally Seymour, Bing V. Li
Influence of solvents on the variety of crystalline forms of erythromycin
The influence of the organic solvents widely used in the pharmaceutical industry (acetone, methylethylketone, ethanol, and isopropanol) both in the presence and in the absence of water on the crystallization behavior of...
Development of a Generic Anti-PEG Antibody Assay Using BioScale’s Acoustic Membrane MicroParticle Technology
Immunogenicity testing for PEGylated biotherapeutics should include methods to detect both anti-protein and anti-PEG antibodies (anti-PEG). Although some methods have been published for the detection of anti-PEG antibodi...
CYP3A4 Mediates Oxidative Metabolism of the Synthetic Cannabinoid AKB-48
The online version of this article (doi:10.1208/s12248-015-9788-7) contains supplementary material, which is available to authorized users.
The MDR1 C3435T polymorphism: Effects on P-glycoprotein expression/function and clinical significance
Hepatic Metabolism and Disposition of Baicalein via the Coupling of Conjugation Enzymes and Transporters—In Vitro and In Vivo Evidences
Baicalein (Ba) was found to be subject to serious first-pass metabolism after oral administration. We previously revealed the important role of intestine in the low oral bioavailability of Ba. The present study aims to e...