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Pharmaceutical quality by design : principles and applications /
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Academic Press,
[2019]
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 245 | 0 | 0 | |a Pharmaceutical quality by design : |b principles and applications / |c edited by Sarwar Beg, Md Saquib Hasnain. |
| 264 | 1 | |a London : |b Academic Press, |c [2019] | |
| 300 | |a 1 online resource : |b illustrations (some color) | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 500 | |a Includes index. | ||
| 588 | 0 | |a Online resource; title from PDF title page (EBSCO, viewed March 29, 2019). | |
| 520 | |a Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. | ||
| 505 | 0 | |a Front Cover; Pharmaceutical Quality by Design: Principles and Applications; Copyright; Contents; Contributors; Preface; Chapter 1: Introduction to Quality by Design (QbD): Fundamentals, Principles, and Applications; 1. Introduction; 2. Evolution of QbD concept; 3. Pharmaceutical Quality System: A Newer Quality Trend; 4. ICH Guidelines on QbD and Related Paradigms; 5. Philosophy and Principles of QbD; 6. Stakeholders of QbD; 7. Key Elements and Steps for Execution of QbD; 8. Current Regulatory Perspectives on QbD; 9. QbD as a Lifecycle Approach; 9.1. Preclinical Developmental Phase | |
| 505 | 8 | |a 9.2. Nonclinical and Clinical Phase9.3. Scale-Up Phase; 9.4. Marketing Approval Phase; 10. Application of QbD in Product Development; 10.1. Development of New and Generic Drug Products; 10.2. Development of Nanopharmaceuticals; 10.3. Development of Biosimilars; 10.4. Development of Analytical Methods; 10.5. Development of Drug Substances; 10.6. Development of Dissolution Methods; 10.7. Development of Bioequivalence Methods; 10.8. Development of Stability Testing Methods; 10.9. Development of Clinical Trial Activities; 11. Lifespan of the QbD Concept in the Industrial Milieu; 12. Conclusion | |
| 505 | 8 | |a 8.5. Control of the Preparation9. Concerns, Problems, and Queries About QbD; 10. Solutions and Benefits Provided by QbD; References; Chapter 3: Application of Design of Experiments (DoE) in Pharmaceutical Product and Process Optimization; 1. Introduction; 2. A Brief History of Experimental Designs; 3. Evolution of Systematic Quality Approaches; 4. ICH Initiatives and Quality by Design; 5. One-Factor-at-a-Time (OFAT) Approach of Experimentation; 6. Comparison of Traditional OFAT vs Modern DoE; 7. General Considerations on Designing Experiments; 8. Fundamental of Applying DoE | |
| 505 | 8 | |a 9. Vital Principles of Experimental Designs9.1. Randomization; 9.2. Replication; 9.3. Blocking; 10. Steps in Performing DoE; 10.1. Defining the Problem; 10.2. Establishment of Cause-and-Effect Relationship; 10.3. Factor Screening; 10.4. Selection of the Factor Ranges; 10.5. Selection of the Response Variable(s); 10.6. Factor Optimization; 10.7. Performing the Experiment; 10.8. Factor-Response Confirmation; 10.9. Mathematical Modeling in Experimental Design; 10.10. Statistical Data Analysis; 10.11. Selection of Experimental Designs; 10.12. Types of Experimental Designs | |
| 504 | |a Includes bibliographical references and index. | ||
| 650 | 0 | |a Drug development |x Quality control. | |
| 650 | 0 | |a Drugs |x Design |x Quality control. | |
| 650 | 0 | |a Drugs |x Design. | |
| 650 | 0 | |a Quality control. | |
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| 700 | 1 | |a Beg, Sarwar, |d 1987- |e editor. | |
| 700 | 1 | |a Hasnain, Md Saquib, |d 1984- |e editor. | |
| 776 | 0 | 8 | |i Print version: |t Pharmaceutical quality by design. |d London : Academic Press, [2019] |z 0128157992 |z 9780128157992 |w (OCoLC)1065720710 |
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9780128157992 |z Texto completo |