The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to...

While the safety assessment ("biocompatibility") of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since...

"Statistics and Experimental Design for Toxicologists: Second Edition" von Shayne C. Gad ist ein umfassendes Handbuch, das sich auf die Anwendung statistischer Methoden und experimentellen Designs in der Toxikologie konzentriert. Es...