Cover image for Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development
Title:
Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development
Author:
Breitkreitz, Márcia Cristina. editor.
ISBN:
9783031315053
Edition:
1st ed. 2023.
Physical Description:
X, 266 p. 62 illus., 46 illus. in color. online resource.
Series:
AAPS Introductions in the Pharmaceutical Sciences, 10
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. .
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