For subchronic systemic toxicity studied via implantation, what is the basis for determining the implantation dose, and how is the conversion between animals and humans handled?

Based on the equivalent coefficient between test animals and humans, the dose should be appropriately increased since it is difficult to obtain IC50 for medical devices. Currently, a 50-100 times increase is used based on toxicological research data, considering practical feasibility during testing.

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For Subchronic Systemic Toxicity Studied Via Implantation, What Is The Basis For Determining The Implantation Dose, And How Is The Conversion Between Animals And Humans Handled?

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