HIGHLIGHTS
- who: FDA/CDER from the Center for Drug have published the paper: Bioanalytical Method Validation Guidance for Industry, in the Journal: (JOURNAL)
- what: If the study sample contains more than one analyte and the analytes are intended to be quantified by different methods, the sponsor should test each method for interference from the other analyte.
- how: Method development includes the optimization of the following bioanalytical parameters (which are discussed in greater detail in section III.B) to ensure that the method is suitable for validation.
- future: Kits with standards and QCs . . .
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