Zdrowie i gospodarka · 26/09/1997

FDA Releases Guidance on Extended Release Oral Dosage Forms Development and Evaluation

The Food and Drug Administration (FDA) has released a guidance document for the pharmaceutical industry on the development, evaluation, and application of in vitro/in vivo correlations for extended release oral dosage forms. This document aims to provide recommendations for pharmaceutical sponsors seeking to submit IVIVC data in support of a new drug application, abbreviated new drug application, or antibiotic drug application.