An approach that aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing of medicines.
Published in Chapter:
Applications of Design of Experiments to Pharmaceutical Quality Control
Evelin Gutiérrez Moreno (Universidad Politécnica de Pachuca, Mexico), José A. Rodriguez Ávila (Universidad Autónoma del Estado de Hidalgo, Mexico), and Julián Cruz Borbolla (Universidad Autónoma del Estado de Hidalgo, Mexico)
Copyright: © 2022
|Pages: 23
DOI: 10.4018/978-1-7998-9613-5.ch001
Abstract
Quality control in the pharmaceutical sector as in other areas of industry should ideally be developed from the design to avoid the emergence of problems in the future. Endless quality control tests do not always represent a solution. Quality is considered to be designed according to the needs and use of a product. This chapter briefly presents a description of the use of experiment designs in pharmaceutical analysis; for example, the factors involved in the drug delivery system are described, and the variables are measured to define the level of quality achieved according to the objectives. This chapter includes information on using factorial, fractional, composite central, Taguchi, Plackett-Burman, Box-Behnken, and mixture experimental designs.