Introduction to quality by design in pharmaceutical manufacturing and analytical development /

Dades bibliogràfiques
Autor principal: Márcia Cristina Breitkreitz, Hector Goicoechea
Altres autors: Breitkreitz, Márcia C., Goicoechea, Hector C.
Format: Llibre
Idioma:English
Publicat: Cham, Switzerland : Springer, 2023.
Col·lecció:AAPS introductions in the pharmaceutical sciences
Matèries:
Classic Catalogue: View this record in Classic Catalogue
Taula de continguts:
  • 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