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.

The content

An overview of different bioanalytical methods
An overview of which aspects need to be checked during method validation Examples for the validation of bioanalytical methods
The target groups People with an interest in pharmaceutical and biopharmaceutical topics People who want to pursue a career in the pharmaceutical industry or who want to get to know related areas of expertise
The author

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. This book is a translation of an original German edition. The translation was done with the help of artificial intelligence (machine translation by the service DeepL.com). A subsequent human revision was done primarily in terms of content, so that the book will read stylistically differently from a conventional translation.

Auteur