RE: RE: Can regulators soften their thinking on CV limits and focus on other issues.
Contribution from SAURABH... written on 4/2/2012 at 14:14
Original contribution: RE: Can regulators soften their thinking on CV limits and focus on other issues. written by JD Mallet on 4/1/2012 at 22:04)
I think the dose criteria or criticality is based on NOAEL with in vivo testing, hence application of 10ppm criteria is subjective and should be justified if has to exceed in Solids and Liquids.
Speaking about product impurities-they are Quantified and Qualified to remain in prescribed limits in a single dose (similar to what you apply for your MAC value).
Residue carry has to be stringent given the fact that pharmacological activity of potent drug is possible on low doses or sensitive patient.
Risk assessment is always a tool.
Form! Any other view…
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