This book describes the validation of bioanalytical methods. In the quality control of biological drugs, bioanalytical methods are often 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...
This book describes the validation of bioanalytical methods. In the quality control of biological drugs, bioanalytical methods are often 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...