Posting: # 19329
I've been looking for any guidance of BE study for spiramycine but have not found anything. I found some articles, some used microbiological assay, some used HPLC methods (detect all 3 components or only Spiramycine I). As spiramycine have 3 main components (I: 85%, II: 5%; III: 10%), all have therapeutic effect, what APIs do we need to measure: all of these components individually, or just Spiramycine I?
THanks in advance!