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Analytical method validation and instrument performance verification / / editors, Chung Chow Chan [et al.]
| Analytical method validation and instrument performance verification / / editors, Chung Chow Chan [et al.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2004 |
| Descrizione fisica | 1 online resource (315 pages) : illustrations |
| Disciplina | 610/.28 |
| Altri autori (Persone) | ChanChung Chow |
| Soggetto topico |
Drugs - Analysis - Methodology - Evaluation
Laboratories - Equipment and supplies - Evaluation Laboratories - Instruments - Evaluation |
| ISBN |
1-280-36739-3
9786610367399 0-470-30755-2 0-471-46371-X 0-471-46372-8 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee -- Dissolution method validation / Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee --
Development and validation of automated methods / Chantal Incledon and Herman Lam -- The analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo -- The procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam -- Performance verification of UV-VIS spectrophotometers / Herman Lam -- Performance verification of HPLC / Herman Lam. |
| Record Nr. | UNINA-9910143214103321 |
| Hoboken, N.J., : John Wiley & Sons, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Analytical method validation and instrument performance verification / / edited by Chung Chow Chan ... [et al.]
| Analytical method validation and instrument performance verification / / edited by Chung Chow Chan ... [et al.] |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2004 |
| Descrizione fisica | 1 online resource (315 pages) : illustrations |
| Disciplina | 610/.28 |
| Altri autori (Persone) | ChanChung Chow |
| Soggetto topico |
Drugs - Analysis - Methodology - Evaluation
Laboratories - Equipment and supplies - Evaluation Laboratories - Instruments - Evaluation |
| ISBN |
1-280-36739-3
9786610367399 0-470-30755-2 0-471-46371-X 0-471-46372-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee -- Dissolution method validation / Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee --
Development and validation of automated methods / Chantal Incledon and Herman Lam -- The analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo -- The procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam -- Performance verification of UV-VIS spectrophotometers / Herman Lam -- Performance verification of HPLC / Herman Lam. |
| Record Nr. | UNINA-9910815446403321 |
| Hoboken, N.J., : John Wiley & Sons, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Practical approaches to method validation and essential instrument performance verification / / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang
| Practical approaches to method validation and essential instrument performance verification / / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (415 pages) |
| Disciplina | 615/.1901 |
| Altri autori (Persone) |
ChanChung Chow
LamHerman ZhangXue-Ming |
| Soggetto topico |
Drugs - Analysis - Methodology - Evaluation
Laboratories - Equipment and supplies - Evaluation Laboratories - Instruments - Evaluation |
| ISBN |
1-118-06031-8
1-282-88344-5 9786612883446 0-470-63071-X 0-470-63070-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | (Publisher-supplied data ) Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification / Phase Appropriate Method Validation / Analytical Method Verification, Method Revalidation, and Method Transfer / Validation of PAT Applications / The Validation of Near Infrared Systems for Raw Material Identification / Cleaning Validation / Risk Based Validation of laboratory Information Management Systems (LIMS) / Performance Qualification and Verification of Balance / Performance Verification of NIR Spectrophotometers / Operational Qualification in Practice for Gas Chromatography Instruments / Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection / Instrument Qualification and Performance Verification for Particle Size Instruments / Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers / Instrument Performance Verification ? Micro Pipettes / Instrument Qualification and Performance Verification for Automated Liquid Handling Systems / Performance Qualification and Verification in Powder X-ray Diffraction. |
| Record Nr. | UNINA-9910140857303321 |
| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Practical approaches to method validation and essential instrument performance verification / / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang
| Practical approaches to method validation and essential instrument performance verification / / edited by Chung C. Chan, Herman Lam, Xue-Ming Zhang |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (415 pages) |
| Disciplina | 615/.1901 |
| Altri autori (Persone) |
ChanChung Chow
LamHerman ZhangXue-Ming |
| Soggetto topico |
Drugs - Analysis - Methodology - Evaluation
Laboratories - Equipment and supplies - Evaluation Laboratories - Instruments - Evaluation |
| ISBN |
1-118-06031-8
1-282-88344-5 9786612883446 0-470-63071-X 0-470-63070-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | (Publisher-supplied data ) Overview of Risk Based Approach to Phase Appropriate Validation and Instrument Qualification / Phase Appropriate Method Validation / Analytical Method Verification, Method Revalidation, and Method Transfer / Validation of PAT Applications / The Validation of Near Infrared Systems for Raw Material Identification / Cleaning Validation / Risk Based Validation of laboratory Information Management Systems (LIMS) / Performance Qualification and Verification of Balance / Performance Verification of NIR Spectrophotometers / Operational Qualification in Practice for Gas Chromatography Instruments / Performance Verification on RI, Fluorescence, Evaporative Light Scattering Detection / Instrument Qualification and Performance Verification for Particle Size Instruments / Method Validation, Qualification, and Performance Verification for Total Organic Carbon (TOC) Analyzers / Instrument Performance Verification ? Micro Pipettes / Instrument Qualification and Performance Verification for Automated Liquid Handling Systems / Performance Qualification and Verification in Powder X-ray Diffraction. |
| Record Nr. | UNINA-9910821156303321 |
| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
