Statistical approaches to specification setting with application to bioassay.
Statistics has a role to play in the establishment of specification limits. This is particularly true in bioassays where the levels of uncertainty in the process and assay can be substantial. The use of statistical approaches can aid manufacturers in setting meaningful specifications and help to evaluate the ability of their processes to meet specifications long-term.
Dillard
R F
RF
Pharmacia, Skokie, IL 60077, USA. robert.f.dillard@pharmacia.com
D001681:Biological Assay / Q000379:methods / Q000592:standards*; D013223:Statistics as Topic