Could someone please clarify the difference between an Assay and a Method? My understanding is that a Method is more specific than an Assay. The follow up question is that when you have to validate a quantitative assay is it feasable evaluate LOD and LOQ?

Thank you

Assuming that you are talking about pharmaceuticals, the words "Assay" and "Method" are used more or less interchangeably in the USP. Whether Quantitation and/or Detection Limits have to be determined depends on the purpose of the assay (method). The USP now follows the ICH guidelines. You can get those by following the links in: http://www.mcclurenet.com (thanks to Fred Klink for first posting this back in October).

You might also want to do a keyword search here on Chrom Forum, there have been a number of threads on the topic.

Hope this helps.

Some QC and Stability labs consider a "Method" to be ALL of the release tests that get performed on a product before shipping. In addition to Assay (usually a potency test of a composite sample) - there are ID tests, tests of physical properties, and in the case of solid dosage form pharmaceuticals (tablets, capsules etc.) there are dosage uniformity and dissolution tests to be considered. Uniformity and dissolution tests are also referred to as assays as are the titrimetric, UV and other tests used to arrive at an Assay result.