An industrial case study: QbD to accelerate time-to-market of a drug product

• Main Authors: Madalena Testas (Author), Tiago da Cunha Sais (Author), Leonardo Piccoli Medinilha (Author), Katia Nami Ito Niwa (Author), Lucas Sponton de Carvalho (Author), Silvia Duarte Maia (Author), Anderson Flores (Author), Lígia Pedroso Braz (Author), José Cardoso Menezes (Author), Cássio Yooiti Yamakawa (Author)
• Format: Book
• Published: SpringerOpen, 2021-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

Abstract The use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial pha...