Which approach, toxicity (in term of LD50) or potency (in term of the dose) is better for bracketing the products for cleaning validation? I think potency i.e. dose criterion should be considered as long as dose is available as we generally practice so for setting the acceptance criteria. Am I right? Can anybody suggest me the right approach.
Both parameters should be taken into consideration for bracketing purposes.
Evaluation and conclusion must be based on both critetia.
Best regards,
I suggest not only take LD50 and potency, but also consider the API´s relative solubility. I suggest to make like a “puntuation” table based on these criteria, where the product with the most punctuation results in the worst case product.