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Heres what you need to know about the evolving market, growing safety concerns, and new regulatory efforts: To view or add a comment, sign in The FDA's statistical formula that defined bioequivalence as a range---a generic drug's concentration in the blood couldn't fall below 80% or rise above 125% of the brand names's concentration, using a 90% confidence interval---still allowed for a potential outside range of 45% among generics labelled as being the same

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Analytical sensitivity of the method was 0.2 ng/ml

It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, and alterations and modifications in the illustrated invention, and further applications of the principles of the invention as illustrated therein are herein contemplated as would normally occur to one skilled in the art to which the invention relates