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Introduction to quality by design in pharmaceutical manufacturing and analytical development / Márcia Cristina Breitkreitz, Hector C. Goicoechea, editors. - Cham, Switzerland : Springer, 2023. - x, 266 pages : illustrations (some color) ; 24 cm - AAPS introductions in the pharmaceutical sciences . - AAPS introductions in the pharmaceutical sciences .

Includes index.

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

ISBN: 9783031315046

Dewey Class. No.: 615.19