Swartz, Michael (Michael E.), 1958-
Handbook of analytical validation / Michael E. Swartz. -- Hoboken : CRC Press, 2012. -- 1 online zdroj (218 stran). -- Obsahuje: Front Cover; Contents; Preface; Chapter 1: Introduction to Analytical Method Validation; Chapter 2: Analytical Instrument Qualification; Chapter 3: HPLC Method Development and Optimization with Validation in Mind; Chapter 4: Method Validation Basics; Chapter 5: Robustness and System Suitability; Chapter 6: Setting Specifications and Investigating Out-of-Specification Results; Chapter 7: Validation by Type of Method; Chapter 8: Analytical Method Transfer; Chapter 9: Implementing New Technology in a Regulated Environment; Glossary of Terms Related to Chromatographic Method Validation. -- Resumé: Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types. -- ISBN : 9781420014488 (online ; pdf). -- 142001448X.
testování léků. chromatografická analýza. farmaceutická chemie. elektronické knihy
615.038. 615:54. 543.54. (0.034.2:08)