You are a pharmacologist working for a large pharmaceutical company. A team of researchers at the company reported that a new experimental drug’s therapeutic index was 10. However, providing no other information about the index, you are left wondering about how to interpret this finding. Based on what you know about how therapeutic indexes are determined, provide a question to ask the research team and indicate the rationale for this question.

Question

What will be an ideal response?

Answer 1

Ans: A comprehensive answer would note that TIs are derived from effective dose (ED) and toxic dose (TD) values. A safe TI would be calculated using an ED99 and a TD1, or something more extreme. A likely question to be asked would be “What ED and TD values were used?” Another might be “How many subjects experienced toxic effects at a high ED value (e.g., ED99)?” Another might be, “Is this also a Certain Safety Index?”