Terms & Definitions


• 257 Organization for Economic Cooperation and Development (OECD)


An international economic organization of 34 countries founded in 1961 to stimulate economic progress and world trade. It has issued a set of good laboratory practice (GLP) guidelines that are followed in multiple (e.g., European) countries.


• 258 orthogonal


Within a quantitative method, refers to at least two separation modes that demonstrate different selectivities, the optimized combination of which is favorable. The separation modes can be extractive, chromatographic or mass spectrometric.


• 259 out of specification (OOS) investigation


An initial laboratory finding that is outside of predefined limits requires a documented investigation of the cause, assessment of the potential impact, corrective action and preventive action.


• 260 outlier


A result that differs unreasonably from the others in a set of data, and is therefore a suspect measurement. Outliers may be verified as such using statistical methods.


• 261 over-curve concentration


A sample with concentration above the validated range of the analytical method (> upper limit of quantitation [ULOQ]).


• 262 parallel-line analysis (PLA)


A statistical method for the comparison of potency between a reference product and test product. It is used to calculate relative potency by comparing the dose–response curves of the two products.


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S61


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