Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development
Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivati...
שמור ב:
| מחבר תאגידי: | |
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| מחברים אחרים: | , |
| פורמט: | אלקטרוני ספר אלקטרוני |
| שפה: | אנגלית |
| יצא לאור: |
Cham :
Springer International Publishing : Imprint: Springer,
2023.
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| מהדורה: | 1st ed. 2023. |
| סדרה: | AAPS Introductions in the Pharmaceutical Sciences,
10 |
| נושאים: | |
| גישה מקוונת: | https://doi.org/10.1007/978-3-031-31505-3 |
| תגים: |
הוספת תג
אין תגיות, היה/י הראשונ/ה לתייג את הרשומה!
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תוכן הענינים:
- Part 1: Quality by Design (QbD)
- Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements
- Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology
- Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology
- Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology
- Chapter 5. Quality by Design in pharmaceutical product and process development
- Chapter 6. A Quality by Design update on nano-drug delivery systems
- Chapter 7. Control strategies of solid dosage forms by PAT tools
- Part 2: Analytical Quality by Design (AQbD)
- Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives
- Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR)
- Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals
- Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds. .