drug substance和drug products的区别?
drug substance和drug products的区别是什么?谢谢!
参考答案:Drug substance: The active ingredient intended to diagnose, treat, cure, or prevent disease or affect the structure or function of the body, excluding other inactive substances used in the drug product.
Drug Products: The finished dosage form (tablet, capsule, etc.) that contains a drug substance--generally, but not necessarily, in association with other active or inactive ingredients.
简言之,前者就是那些可以药用的物质,比如人参、枸杞或其它化学物质。。。而后者只是最终制成的你可以服用的药,它们可以含drug substance,但并非必须,也可能含有本身没有药用的物质。