Good afternoon! At me such question: at calculations of criterion of toxicity at carrying out of validation of clearing NOEL value of lethal dose LD50 the medicinal preparation or an active substance is taken? And where such information can be found?
NOAEL (or no observed adverse effect level) and in particular the ADE (or acceptable daily exposure, a measure of the molecule’s toxicity). LD50 is not sufficient since it does not apply to humans and the 1/1000 safety factor (fudge factor) has no scientific justification. The ADE can be calculated by a toxicologist from clinicals phase II (for a generic) or available from www.affygility.com
Newer NDA’s have not been assigned an ADE yet. Remember ‘Botox’ is an analog of Clostridium Botulinum neurotoxin, so the ADE applies to biologicals.