Introduction to quality by design in pharmaceutical manufacturing and analytical development /
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| Other Authors: | , |
| Format: | Book |
| Language: | English |
| Published: |
Cham, Switzerland :
Springer,
2023.
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| Series: | AAPS introductions in the pharmaceutical sciences
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| Subjects: | |
| Classic Catalogue: | View this record in Classic Catalogue |
Table of Contents:
- 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