Method Validation in Pharmaceutical Analysis (Record no. 15830)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 01611nam a2200181Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 140223b2005 xxu||||| |||| 00| 0 eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9783527312559 |
| Terms of availability | 0.00 |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 615.1901 |
| Item number | MET |
| 245 ## - TITLE STATEMENT | |
| Title | Method Validation in Pharmaceutical Analysis |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) | |
| Place of publication, distribution, etc | Weinheim |
| Name of publisher, distributor, etc | Wiley-VCH Verlag Gmbh |
| Date of publication, distribution, etc | 2005 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 403p |
| 500 ## - GENERAL NOTE | |
| General note | Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities. Show More Show Less |
| 600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME | |
| Personal name | Pharmaceutical Analysis |
| 9 (RLIN) | 105057 |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ermer, Joachim |
| Relator term | Editor |
| 9 (RLIN) | 105058 |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Miller, John H. McB |
| Relator term | Editor |
| 9 (RLIN) | 105059 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Item type | Book |
| 995 ## - RECOMMENDATION 995 [LOCAL, UNIMARC FRANCE] | |
| Origin of item (home branch) (free text) | Pharmacy Reference |
| Genre | P0002177 |
| Section | 615.1901 |
| Recipient parent organisation code | P0002177 |
No items available.