Quality by Design (QbD) Design of Experiments (DOE)

USFDA, EMA, ICH Guidelines on Pharmaceutical Development for Medicinal Products, Dosage Forms, Drug Substances (APIs), Quality by Design (QbD)

• ICH Q8(R2): Pharmaceutical Development (For dosage forms)
  • ICH Q8, Q9 and Q10: Questions & Answers (R4)
  • ICH Training presentations: Training Programme for Q8/Q9/Q10
• ICH Q11: Development And Manufacture Of Drug Substances (Chemical Entities (APIs) And Biotechnological/Biological Entities)
  • ICH Q11:Questions and Answers
  • ICH Training presentations: Q11 Training Materials
• EMA (European Medicines Agency): Quality: Quality by Design (QbD) (EMA references and links to ICH Q8, Q9, Q10 for QbD)
• USFDA: Q8(R2) Pharmaceutical Development (Same as ICH Q8(R2))
• Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019 (Journal Article Judith P. ter Horst, Sada L. Turimella, Frans Metsers & Alex Zwiers; Therapeutic Innovation & Regulatory Science volume 55, pages583–590 (2021)