Handbook of analytical validation (Record no. 10438)
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| 000 -LEADER | |
|---|---|
| fixed length control field | nam a22 4500 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20191205155543.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 191205b xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780824706890 |
| Qualifying information | CRC |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780367268619 |
| Qualifying information | book |
| 040 ## - CATALOGING SOURCE | |
| Transcribing agency | AIKTC-KRRC |
| 041 ## - LANGUAGE CODE | |
| Language code of text/sound track or separate title | ENG |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Edition number | DDC23 |
| Classification number | 543 |
| Item number | SWA/KRU |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 3803 |
| Personal name | Swartz, Michael |
| 245 ## - TITLE STATEMENT | |
| Title | Handbook of analytical validation |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Boca Raton |
| Name of publisher, distributor, etc. | CRC Press |
| Date of publication, distribution, etc. | 2012 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | xiv, 206p. |
| Other physical details | | Binding- Hard Bound | |
| Dimensions | 23.5*16 cm |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | 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 of methods used in the regulatory environment Simplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry. |
| Expansion of summary note | Table of Contents Introduction to Analytical Method Validation Introduction The Drug Development Process FDA Hierarchy and Organization The International Conference on Harmonization AMV Guidance The Validation Process Training Conclusion Analytical Instrument Qualification Introduction Components of Data Quality The AIQ Process Roles and Responsibilities Software Validation and Change Control AIQ Documentation Instrument Categories Conclusion HPLC Method Development and Optimization with Validation in Mind Introduction HPLC Method Development Approaches Method Goals HPLC Method Development Instrumentation Method Optimization Summary Method Validation Basics Introduction Method Validation Guidelines Terms and Definitions Validation According to Method Type Documentation Summary Robustness and System Suitability Introduction Robustness Studies for Method Validation Robustness Study Experimental Design Analyzing the Results Documentation and Reporting System Suitability Tests System Suitability Standards System Suitability Protocol Method Adjustments to Meet System Suitability Requirements Conclusion Setting Specifications and Investigating Out-of-Specification Results Introduction Guidance for Setting Specifications General Concepts for Developing and Setting Specifications Universal Tests/Criteria Specific Tests/Criteria: New Drug Substances Specific Tests/Criteria: New Solid Oral Drug Products Specific Tests/Criteria: New Oral Liquid Drug Products Specific Tests/Criteria: Parenteral Drug Products Decision Trees OOS Background Preventing OOS Results Identifying and Assessing OOS Test Results Investigating OOS Test Results Concluding the OOS Investigation Validation by Type of Method Introduction Validation of Impurity Methods Developing and Validating SIMs Developing and Validating Dissolution Procedures Bioanalytical Methods Validating Peptide Mapping Methods Cleaning Method Validation Analytical Method Transfer Introduction Terms, Definitions, and Responsibilities Analytical Method Transfer Options Documentation of Results: The AMT Report Potential AMT Pitfalls Implementing New Technology in a Regulated Environment Introduction Changes to an Approved Method What Constitutes a Change to a Method? Implement an Existing Standard Method Implement an Existing Standard Method with Adjustments Implement an Existing Standard Method with Changes Glossary of Terms Related to Chromatographic Method Validation Appendix 1 Example Method Validation Protocol |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| 9 (RLIN) | 5009 |
| Topical term or geographic name entry element | GENERAL CHEMISTRY |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| 9 (RLIN) | 3804 |
| Personal name | Krull, Ira S. |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | |
| Koha item type | Text Books |
| Withdrawn status | Lost status | Source of classification or shelving scheme | Damaged status | Not for loan | Collection code | Permanent Location | Current Location | Shelving location | Date acquired | Source of acquisition | Cost, normal purchase price | Full call number | Barcode | Date last seen | Cost, replacement price | Price effective from | Koha item type |
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| Reference | School of Pharmacy | School of Pharmacy | Reference Section | 2019-12-13 | 2 | 1996.00 | 543 SWA/KRU | B4065 | 2020-10-26 | 2495.00 | 2019-12-13 | Text Books |