Introduction to quality by design in pharmaceutical manufacturing and analytical development

Introduction to quality by design in pharmaceutical manufacturing and analytical development / Márcia C. Breitkreitz, Hector C. Goicoechea, editors.

Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivati...

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Bibliographic Details
Other Authors: Breitkreitz, Márcia C. (Márcia Cristina) (Editor), Goicoechea, Hector C. (Hector Casimiro), 1961 May 15-
Format: eBook
Language:English
Published: Cham, Switzerland : Springer, [2023]
Series:AAPS introductions in the pharmaceutical sciences,
Subjects:
Drugs > Design > Quality control.
Pharmaceutical industry > Quality control.
Drugs > Design.
Pharmaceutical industry > Quality control
Online Access:Click for online access
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.

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