Polymorphism is a essential information !
Specific topics
28 février 2023
According to ICH Q6A, polymorphism is described as:
« The occurence of different crystalline forms of the same drug substance. This may include solvation or hydration products (also know as pseudopolymorphs) and amorphous forms. »
Polymorphism is essential in pharma development for lead selection, solid form selection, regulatory affairs, IP, crystallization process development, robustness, and more.
