Handbook of Analytical Validation

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.Krull, Ira S. is the author of 'Handbook of Analytical Validation ', published 2007 under ISBN 9780824706890 and ISBN 0824706897.