Chromatography Forum

Dear everyone,

I am about to develop a method for the determination of ivermectin in swine plasma, but I am not sure which guideline would be appropriate. Would 2002/657/EC be ok?

I always thought that reference was for regulatory methods for residues in food, but the preamble does mention live animals. In the US, the guidance for food residue methods is not the same as that for methods that would support a PK study, though there is substantial overlap.

I would suggest guidance VICH GL49, but even that one tends to refer to tissue methods.

If this is for work that will be submitted to support a generic vet drug approval, I suggest that you check with the applicable regulatory authorities.

Thank you for your help!