Validation of a Level A IVIVC can be one of two types, internal or external, where:
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An internal validation uses the drug formulations that were involved in the development of the IVIVC.
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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:
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An internal validation requires the following criteria:
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< 15% absolute prediction error (PE) for Cmax and AUC for each formulation.
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< 10% mean absolute prediction error (PE) Cmax and AUC.
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An external validation requires < 10% absolute prediction error (PE) for Cmax and AUC for each formulation.