Handbook of analytical quality by design:
Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and...
Gespeichert in:
| Weitere beteiligte Personen: | , , , |
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| Format: | Elektronisch E-Book |
| Sprache: | Englisch |
| Veröffentlicht: |
London San Diego, CA
Academic Press
[2021]
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| Schlagwörter: | |
| Links: | https://learning.oreilly.com/library/view/-/9780128203330/?ar |
| Zusammenfassung: | Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance. |
| Beschreibung: | 1. Introduction to analytical quality by design -- 2. Analytical Quality by Design for spectrophotometric method development -- 3. Analytical Quality by Design for liquid chromatographic method development -- 4. Analytical Quality by Design for gas chromatographic method development -- 5. Analytical Quality by Design for size-exclusion chromatography -- 6. Analytical Quality by Design for ion-exchange chromatography -- 7. Analytical Quality by Design for LC-MS/MS method development -- 8. Analytical Quality by Design for HPTLC method development -- 9. Analytical Quality by Design for capillary electrophoresis -- 10. Quality by Design based development of vibrational spectroscopy methods -- 11. Quality by Design based development of atomic absorption spectroscopy methods -- 12. Quality by Design based development of non-destructive analytical techniques -- 13. Design space considerations for flexibility in analytical method development. - Includes bibliographical references and index. - Description based on online resource; title from digital title page (viewed on March 13, 2021) |
| Umfang: | 1 Online-Ressource |
| ISBN: | 0128203331 9780128203330 |
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| 500 | |a 1. Introduction to analytical quality by design -- 2. Analytical Quality by Design for spectrophotometric method development -- 3. Analytical Quality by Design for liquid chromatographic method development -- 4. Analytical Quality by Design for gas chromatographic method development -- 5. Analytical Quality by Design for size-exclusion chromatography -- 6. Analytical Quality by Design for ion-exchange chromatography -- 7. Analytical Quality by Design for LC-MS/MS method development -- 8. Analytical Quality by Design for HPTLC method development -- 9. Analytical Quality by Design for capillary electrophoresis -- 10. Quality by Design based development of vibrational spectroscopy methods -- 11. Quality by Design based development of atomic absorption spectroscopy methods -- 12. Quality by Design based development of non-destructive analytical techniques -- 13. Design space considerations for flexibility in analytical method development. - Includes bibliographical references and index. - Description based on online resource; title from digital title page (viewed on March 13, 2021) | ||
| 520 | |a Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance. | ||
| 650 | 0 | |a Pharmaceutical industry |x Quality control | |
| 650 | 0 | |a Drug development |x Quality control | |
| 650 | 0 | |a Drug development |x Methodology | |
| 650 | 0 | |a Drugs |x Design |x Quality control | |
| 650 | 0 | |a Drugs |x Design |x Methodology | |
| 650 | 4 | |a Industrie pharmaceutique ; Qualité ; Contrôle | |
| 650 | 4 | |a Médicaments ; Développement ; Qualité ; Contrôle | |
| 650 | 4 | |a Médicaments ; Développement ; Méthodologie | |
| 650 | 4 | |a Médicaments ; Conception ; Qualité ; Contrôle | |
| 650 | 4 | |a Médicaments ; Conception ; Méthodologie | |
| 650 | 4 | |a Pharmaceutical industry ; Quality control | |
| 700 | 1 | |a Beg, Sarwar |d 1987- |e HerausgeberIn |4 edt | |
| 700 | 1 | |a Hasnain, Md Saquib |d 1984- |e HerausgeberIn |4 edt | |
| 700 | 1 | |a Rahman, Mahfoozur |d 1984- |e HerausgeberIn |4 edt | |
| 700 | 1 | |a Almalki, Waleed H. |e HerausgeberIn |4 edt | |
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| format | Electronic eBook |
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| id | ZDB-30-ORH-10436632X |
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| indexdate | 2025-01-17T11:22:13Z |
| institution | BVB |
| isbn | 0128203331 9780128203330 |
| language | English |
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| publishDate | 2021 |
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| spelling | Handbook of analytical quality by design edited by Sarwar Beg, Md Saquib Hasnain, Mahfoozur Rahman, Waleed H. Almalki London San Diego, CA Academic Press [2021] 1 Online-Ressource Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 1. Introduction to analytical quality by design -- 2. Analytical Quality by Design for spectrophotometric method development -- 3. Analytical Quality by Design for liquid chromatographic method development -- 4. Analytical Quality by Design for gas chromatographic method development -- 5. Analytical Quality by Design for size-exclusion chromatography -- 6. Analytical Quality by Design for ion-exchange chromatography -- 7. Analytical Quality by Design for LC-MS/MS method development -- 8. Analytical Quality by Design for HPTLC method development -- 9. Analytical Quality by Design for capillary electrophoresis -- 10. Quality by Design based development of vibrational spectroscopy methods -- 11. Quality by Design based development of atomic absorption spectroscopy methods -- 12. Quality by Design based development of non-destructive analytical techniques -- 13. Design space considerations for flexibility in analytical method development. - Includes bibliographical references and index. - Description based on online resource; title from digital title page (viewed on March 13, 2021) Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance. Pharmaceutical industry Quality control Drug development Quality control Drug development Methodology Drugs Design Quality control Drugs Design Methodology Industrie pharmaceutique ; Qualité ; Contrôle Médicaments ; Développement ; Qualité ; Contrôle Médicaments ; Développement ; Méthodologie Médicaments ; Conception ; Qualité ; Contrôle Médicaments ; Conception ; Méthodologie Pharmaceutical industry ; Quality control Beg, Sarwar 1987- HerausgeberIn edt Hasnain, Md Saquib 1984- HerausgeberIn edt Rahman, Mahfoozur 1984- HerausgeberIn edt Almalki, Waleed H. HerausgeberIn edt 9780128203323 Erscheint auch als Druck-Ausgabe 9780128203323 |
| spellingShingle | Handbook of analytical quality by design Pharmaceutical industry Quality control Drug development Quality control Drug development Methodology Drugs Design Quality control Drugs Design Methodology Industrie pharmaceutique ; Qualité ; Contrôle Médicaments ; Développement ; Qualité ; Contrôle Médicaments ; Développement ; Méthodologie Médicaments ; Conception ; Qualité ; Contrôle Médicaments ; Conception ; Méthodologie Pharmaceutical industry ; Quality control |
| title | Handbook of analytical quality by design |
| title_auth | Handbook of analytical quality by design |
| title_exact_search | Handbook of analytical quality by design |
| title_full | Handbook of analytical quality by design edited by Sarwar Beg, Md Saquib Hasnain, Mahfoozur Rahman, Waleed H. Almalki |
| title_fullStr | Handbook of analytical quality by design edited by Sarwar Beg, Md Saquib Hasnain, Mahfoozur Rahman, Waleed H. Almalki |
| title_full_unstemmed | Handbook of analytical quality by design edited by Sarwar Beg, Md Saquib Hasnain, Mahfoozur Rahman, Waleed H. Almalki |
| title_short | Handbook of analytical quality by design |
| title_sort | handbook of analytical quality by design |
| topic | Pharmaceutical industry Quality control Drug development Quality control Drug development Methodology Drugs Design Quality control Drugs Design Methodology Industrie pharmaceutique ; Qualité ; Contrôle Médicaments ; Développement ; Qualité ; Contrôle Médicaments ; Développement ; Méthodologie Médicaments ; Conception ; Qualité ; Contrôle Médicaments ; Conception ; Méthodologie Pharmaceutical industry ; Quality control |
| topic_facet | Pharmaceutical industry Quality control Drug development Quality control Drug development Methodology Drugs Design Quality control Drugs Design Methodology Industrie pharmaceutique ; Qualité ; Contrôle Médicaments ; Développement ; Qualité ; Contrôle Médicaments ; Développement ; Méthodologie Médicaments ; Conception ; Qualité ; Contrôle Médicaments ; Conception ; Méthodologie Pharmaceutical industry ; Quality control |
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