8. GLOSSARY

Chemical ? Development ? Studies : Studies conducted to scale-up , optimise , and validate the manufacturing process for a new drug substance .New ? Drug ? Substance : The designated therapeutic moiety that has not been previously registered in a region o member state ( also referred to as a new molecular entity or new chemical entity ) .Specified ? Impurity : An impurity that is individually listed and limited with a specific acceptance criterion in the new drug substance specification .