Design of Experiments (DoE) Application in Two Cases of Study in Pharmaceutical Industries

Author(s)

Souza, Romero Moreira ; Bonamichi, Luiz Americo Verginio ; Pereira-Filho, Edenir Rodrigues

• Document type: Journal article
• Source: BRAZILIAN JOURNAL OF ANALYTICAL CHEMISTRY; v. 11, n. 43, p. 171-pg., 2024-04-01.

Abstract

This study illustrates the practical application of Design of Experiments (DoE) in two real-life scenarios within the pharmaceutical industry. The first case involved optimizing a chromatographic method to determine multiple analytes and their degradation products. The primary variable of interest was gradient time, and the most favorable outcomes were achieved at a pH value of 2. In the second case, we conducted a shelf-life study for a veterinary product, revealing that the vial filling variable exerted a statistically significant impact (p-value < 0.05). The incorporation of DoE in both cases played an important role in ensuring the attainment of dependable and statistically validated results. (AU)

• FAPESP's process: 18/08782-1 - Miniaturized and integrated chemical sensors: new fabrication platforms for biological, clinical and environmental applications
• Grantee: Mauro Bertotti
• Support Opportunities: Research Projects - Thematic Grants
• FAPESP's process: 18/19750-3 - Exploring C4D detection for the development of innovative and low-cost microfluidic biosensors
• Grantee: Laís Canniatti Brazaca
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• FAPESP's process: 13/22127-2 - Development of novel materials strategic for integrated analytical devices
• Grantee: Lauro Tatsuo Kubota
• Support Opportunities: Research Projects - Thematic Grants