Table 8 DDI definitions in corpus

IN VIVO STUDY

DDI

Yes

Yes

The PK parameter with the highest priority* must satisfy p-value <0.05 and FC > 1.50 or FC < 0.67

Significant, obviously, markedly, greatly, pronouncedly and etc.

Ambiguous DDI (ADDI)

The PK parameter with the highest priority* in the conditions of p-value <0.05 but 0.67 < FC < 1.50; or FC >1.50 or FC <0.67, but p-value > 0.05.

Modestly, moderately, probably, may, might, and etc.

Non-DDI (NDDI)

The PK parameter with the highest priority*are in the condition of p-value > 0.05 and 0.67 < FC < 1.50

Minor significance, slightly, little or negligible effect, doesn’t interact etc.

IN VITRO STUDY

DDI

Yes

Yes

(0< Ki < 10 or 0< EC50 < 10 microM, and p-value <0.05)

Significant, obviously, markedly, greatly, pronouncedly and etc.

DEI

Ambiguous DDI (ADDI)

(10 < Ki < 100 or 10 < EC50 < 100 microM, and p-value <0.05 or vice versa)

Modestly, moderately, probably, may, might, and etc.

Ambiguous DEI (ADEI)

Non-DDI (NDDI)

(Ki > 100 microM or EC50 > 100 microM, and p-value >0.05)

Minor significance, slightly, little or negligible effect, doesn’t interact etc.

Non-DEI (NDEI)