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Quantics Biostatistics's title: Quantics Biostatistics | A Leading Authority on Statistics in Life Sciences.

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The development of a bioassay is, in essence, a long series of choices. An assay which reaches commercial use is the end of a single path through a near-infinite forest of decision points and optimisations. The eventual goal is to produce an assay which is as accurate and precise as possible, while still being practical to implement on a day-to-day basis. A ...


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In the previous parts of our series covering the latest draft version of USP <1033>, we examined the goals of a bioassay validation study and the basics of accuracy and precision. Then, we discussed Probability of Out-of-Specification (Prob(OOS)) and how this can be used to inform the acceptance criteria for accuracy and precision in a validation study...


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