Is the lowest therapeutic dose set by manufacturer or by what is produced by the contract manufacturer?

When the expert toxicologists at Affygility Solutions review the data; often they often use the lowest therapeutic dose as the point of departure (POD) to establish the occupational exposure limit or acceptable daily exposure value.

The lowest therapeutic dose is the human adult dose that is provided in the scientific literature (i.e. package inserts, regulatory filings, INDs, or NDAs, or other scientific literature).