Handbook of analytical validation /
Krull, Ira S., 1940-
Handbook of analytical validation / Ira S. Krull and Michael Swartz. - New York : London : CRC ; Taylor & Francis [distributor], 2007. - 24 cm.
Includes bibliographical references and index.
1.Introduction to analytical method validation -- 2.Analytical instrument qualification -- 3.HPLC method development and optimization with validation in mind -- 4.Method validation basics -- 5.Robustness and system suitability -- 6.Setting specifications and investigating out-of-specification results -- 7.Validation by type of method -- 8.Analytical method transfer -- 9.Implementing new technology in a regulated environment.
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.
9780824706890 (hbk.) : £79.99 9780824706890 (hbk.) : Đ79.99
2012022035
Chemistry, Analytic--Methodology--Handbooks, manuals, etc
Chemistry, Analytic--Quality control--Handbooks, manuals, etc
Drugs--Analysis--Methodology--Evaluation
Health and Wellbeing.
Analytical chemistry
Medical research
Pharmaceutical chemistry & technology
RS189
543 SWA
Handbook of analytical validation / Ira S. Krull and Michael Swartz. - New York : London : CRC ; Taylor & Francis [distributor], 2007. - 24 cm.
Includes bibliographical references and index.
1.Introduction to analytical method validation -- 2.Analytical instrument qualification -- 3.HPLC method development and optimization with validation in mind -- 4.Method validation basics -- 5.Robustness and system suitability -- 6.Setting specifications and investigating out-of-specification results -- 7.Validation by type of method -- 8.Analytical method transfer -- 9.Implementing new technology in a regulated environment.
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.
9780824706890 (hbk.) : £79.99 9780824706890 (hbk.) : Đ79.99
2012022035
Chemistry, Analytic--Methodology--Handbooks, manuals, etc
Chemistry, Analytic--Quality control--Handbooks, manuals, etc
Drugs--Analysis--Methodology--Evaluation
Health and Wellbeing.
Analytical chemistry
Medical research
Pharmaceutical chemistry & technology
RS189
543 SWA