Drug–Drug Interaction Studies: Regulatory Guidance and An Industry Perspective
Journal Title: The AAPS Journal - Year 2013, Vol 15, Issue 3
Abstract
The online version of this article (doi:10.1208/s12248-013-9470-x) contains supplementary material, which is available to authorized users.
Authors and Affiliations
Thomayant Prueksaritanont, Xiaoyan Chu, Christopher Gibson, Donghui Cui, Ka Lai Yee, Jeanine Ballard, Tamara Cabalu, Jerome Hochman
Effect of rise in simulated inspiratory flow rate and carrier particle size on powder emptying from dry powder inhalers
The purpose of this study was to evaluate the effect of carrier particle size and simulated inspiratory flow increase rate on emptying from dry powder inhalers (DPIs). Several flow rate ramps were created using a compute...
ADME of Biologics—What Have We Learned from Small Molecules?
Thorough characterization and in-depth understanding of absorption, distribution, metabolism, and elimination (ADME) properties of a drug candidate have been well recognized as an important element in small molecule (SM)...
International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences
The objective of this article is to discuss the similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug product...
A Modeling and Simulation Framework for Adverse Events in Erlotinib-Treated Non-Small-Cell Lung Cancer Patients
The online version of this article (doi:10.1208/s12248-015-9815-8) contains supplementary material, which is available to authorized users.
Erratum to: Regioselective Glucuronidation of Andrographolide and Its Major Derivatives: Metabolite Identification, Isozyme Contribution, and Species Differences
Xiangge Tian and Sicheng Liang contributed equally to this work.