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Record Nr. |
UNINA9910829868003321 |
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Autore |
Bliesner David M |
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Titolo |
Validating chromatographic methods [[electronic resource] ] : a practical guide / / David M. Bliesner |
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Pubbl/distr/stampa |
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Hoboken, N.J., : Wiley, c2006 |
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ISBN |
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1-280-64898-8 |
9786610648986 |
0-470-04220-6 |
0-470-04219-2 |
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Descrizione fisica |
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1 online resource (301 p.) |
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Disciplina |
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Soggetti |
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Chromatographic analysis - Validity |
Science - Methodology |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references (p. 283) and index. |
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Nota di contenuto |
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VALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE |
IV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX |
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Sommario/riassunto |
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All the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both |
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