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this book, the validation of bioanalytical methods is described. In the quality control of biological medicinal products, bioanalytical methods are frequently used to check important properties such as the content or possible impurities. The methods used must provide trustworthy results so that no false conclusions are drawn when evaluating the results. The trustworthiness is ensured by validation. The validation of bioanalytical methods is illustrated by means of some examples.
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Validation of bioanalytical methods, Patric U. B. Vogel
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- 2023
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