Introduction to quality by design in pharmaceutical manufacturing and analytical development - Márcia Cristina Breitkreitz, Hector Goicoechea; Breitkreitz, Márcia C.; Goicoechea, Hector C. (Cham, Switzerland : Springer, 2023)
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
Includes index.
PHR
Keywords: Drugs -- Design -- Quality control; Drugs -- Analysis; Pharmaceutical industry -- Quality control; Drugs -- Design; Pharmacy