Zdrowie i gospodarka · 21.02.2012
Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled "Drug Interaction Studies--Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations." The revised draft guidance is intended to provide recommendations for sponsors of new drug applications (NDAs) and biologics license applications (BLAs) for therapeutic biologics regarding in vitro and in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein interactions.