Bioanalytical methods, drug guidelines

There are no detailed recommendations for analytical procedures in the field of biotechnological production of drugs, in contrast to the recommendations made by the FDA for bioanalytical methods [16], The absence of detailed guidelines for analytical method validation in this field is surprising. It is important to validate the quantification of both substrate and product during the process, at definite time intervals, to ensure proper calculation of the kinetics of the process i.e., the coefficients of substrate conversion, and production rates must be adequately calculated. The aim of the study in pa-... 

Since the number of recombinant protein drugs will substantially increase over the next decade, analytical as well as bioan-alytical methods for the characterization of such macromolecules will definitively gain in importance. Especially the vaKdation of bioanalytical methods is of key importance to allow an accurate description of protein drugs. This requires harmonized guidelines, which are not yet existing but seem to be on the way, to accelerate drug development. 

Flavonoids can be determined quantitatively by direct (in glycoside or conjugated form) or indirect (after hydrolysis) analysis. However, sample preparation (e.g., particle size) and solvents used in extraction steps can significantly affect the results [99]. Method development for quantitation is often validated in terms of selectivity, accuracy, precision, recovery, calibration curve, and reproducibility. Biological sample methods have to comply with the Food and Drug Administration (FDA) guidelines for validation of bioanalytical method [100]. 

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