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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Patric U. B. Vogel is a biologist with many years of experience in biopharmaceuticals. He has developed and validated a variety of bioanalytical methods for quality control of pharmaceutical products as a subject matter expert. Since 2019, he has been an author, trainer and consultant in the pharmaceutical field
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 bioanalytical methods is illustrated by some examples.
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Patric U. B. Vogel is a biologist with many years of experience in biophar maceuticals. He has developed and validated a variety of bioanalytical methods for quality control of pharmaceutical products as a subject matter expert. Since 2019, he has been an author, trainer and consultant in the pharmaceutical field.
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