drug-drug interactions
FDA Draft Guidance 2012: Drug Interaction Studies- Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations
May 29 by Pharmaceuticals & Biotechnology EditorThis guidance provides recommendations for sponsors of new drug applications (NDAs) and biologics license applications (BLAs) for therapeutic biologics regulated by CDER regarding in vitro and in vi...
Clinically Relevant Drug Transporters: What Progress is to be Expected in 2012?
December 08 by Pharma IQResearch into drug transporters forms an increasingly important part of the non-clinical development phase, with new fields such as pharmacogenomics offering new approaches to an area that is increa...
