Prix bas
CHF164.00
Habituellement expédié sous 2 à 4 semaines.
Zusatztext "The authors are to be congratulated on producing a concise! readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."-www.chemistryworld.org 1 November 2012 1 Chemistry World 163 Informationen zum Autor Michael E. Swartz, Ira S. Krull "The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV." -www.chemistryworld.org 1 November 2012 1 Chemistry World 163 Zusammenfassung Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. It offers the regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. Inhaltsverzeichnis Introduction to Analytical Method Validation. Analytical Instrument Qualification. HPLC Method Development and Optimization with Validation in Mind. Method Validation Basics. Robustness and System Suitability. Setting Specifications and Investigating Out-of-Specification Results. Validation by Type of Method. Analytical Method Transfer. Implementing New Technology in a Regulated Environment. Glossary of Terms Related to Chromatographic Method Validation. ...
"The authors are to be congratulated on producing a concise, readable and informative book. It is a really useful reference asset covering current regulatory requirements on the validation of new or modified analytical methods from a practical viewpoint. I have seen books of almost twice the size containing half the information. This book should be an integral part of all drug and biotechnology laboratories for both training staff and for comprehensive advice on how to deal with a very wide range of specific issues relating to AMV."www.chemistryworld.org 1 November 2012 1 Chemistry World 163
Auteur
Michael E. Swartz, Ira S. Krull
Texte du rabat
<P>Written for both the drug and biotechnology industries, this handbook has been carefully designed to instruct readers as to the current, regulatory requirements to correctly and properly validate a new or modified analytical method. The book contains the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. It is designed for both small molecules in the conventional pharmaceutical industry, as well as for biopolymers derived from the biopharmaceutical industry. The book is designed to educate the reader into how to fully and correctly modify new or modified analytical methods to meet regulatory requirements.</P>
Résumé
Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. It offers the regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation.
Contenu
Introduction to Analytical Method Validation. Analytical Instrument Qualification. HPLC Method Development and Optimization with Validation in Mind. Method Validation Basics. Robustness and System Suitability. Setting Specifications and Investigating Out-of-Specification Results. Validation by Type of Method. Analytical Method Transfer. Implementing New Technology in a Regulated Environment. Glossary of Terms Related to Chromatographic Method Validation.