US FDA Adopts ICH’s Standards on Friability, Dissolution Tests

April 27, 2010
As part of an ongoing harmonization project intended to reduce paperwork for drugmakers, the FDA has accepted three International Conference on Harmonisation (ICH) standards for dissolution tests, tablet friability and polyacrylamide gel electrophoresis. The FDA’s acceptance allows drugmakers submitting dossiers in ICH regions to use the European, Japanese and U.S. pharmacopoeial texts interchangeably.
International Pharmaceutical Regulatory Monitor