English to Russian Medical Medical: Pharmaceuticals method validation

From the 2013 FDA Draft Guide on Validation:
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A calibration (standard) curve is the relationship between instrument response and known
245 concentrations of the analyte. The relationship between response and concentration should be
246 continuous and reproducible. A calibration curve should be generated for each analyte in the
247 sample. The calibration standards can contain more than one analyte. A calibration curve should
248 be prepared in the same biological matrix as the samples in the intended study by spiking the
249 matrix with known concentrations of the analyte. In rare cases, matrices may be difficult to
250 obtain (e.g., cerebrospinal fluid). In such cases, calibration curves constructed in surrogate
251 matrices should be justified. Concentrations of standards should be chosen on the basis of the
252 concentration range expected in a particular study. A calibration curve should consist of a blank
253 sample (matrix sample processed without analyte or internal standard), a zero sample (matrix
254 sample processed without analyte but with internal standard), and at least six non-zero samples
255 (matrix samples processed with analyte and internal standard) covering the expected range,
256 including LLOQ.
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