Level A IVIVC Validation

Validation of a Level A IVIVC can be one of two types, internal or external, where:

• An internal validation uses the drug formulations that were involved in the development of the IVIVC.

• An external validation uses the drug formulations that were not involved in the development of the IVIVC.

The acceptance criteria for the validation of a Level A IVIVC depends on the validation type, where:

• An internal validation requires the following criteria:

  • < 15% absolute prediction error (PE) for C_max and AUC for each formulation.

  • < 10% mean absolute prediction error (PE) C_max and AUC.

• An external validation requires < 10% absolute prediction error (PE) for C_max and AUC for each formulation.