Cder guidance validating chromatographic methods who is jeezy dating


26-Aug-2019 13:35

An assay ATP should include a statement of accuracy and precision as exemplified by:“The procedure must be able to accurately and precisely quantify drug substance in film-coated tablets over the range of 70%- 130% of the nominal concentration with accuracy and precision such that reported measurements fall within ± 3% of the true value with at least 95% probability.”By including a probability statement in the ATP, the risk of making ill-advised decisions from results will be controlled.The uncertainty range (± 3%) and probability (95%) are established based on a predetermined acceptable level of risk of making an incorrect decision with the data.Individually, these characteristics are not sufficient to assess the quality of reportable results or demonstrate that the method performance is appropriate for its intended use.This is because method performance is fundamentally comprised of both systematic (bias) and random (variance) components.Analogous to process Qb D, the outcome of AQb D is a well understood, fit for purpose, and robust method that consistently delivers the intended performance throughout its lifecycle.The broad knowledge obtained from this process is used to establish a method operable design region (MODR), a multidimensional space based on the method factors and settings that provide suitable method performance.

Other method performance characteristics (linearity, specificity, etc.) do not need to be incorporated in the ATP as they are not directly linked to understanding the agreement of a measurement with the true value.Among these performance characteristics, accuracy and precision provide the critical information needed to quantify an unknown amount of the substance using the method.