Application of Quality by Design and Risk Assessment Principles for the Development of Formulation Design Space

Quality by Design for Biopharmaceuticals: Principles and Case Studies

Volumn , Issue , 2008, Pages 161-174

  Ng, Kingman ^a   Rajagopalan, Natarajan ^a  

^a ELI LILLY AND COMPANY   (United States)

Author keywords

Design and risk assessment quality application; Molecular degradation characterization; Quality by design (QbD) approach

Indexed keywords

EID: 84889386138     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470466315.ch9     Document Type: Chapter

References (4)

1. ICH Q8. Harmonised Tripartite Guideline Pharmaceutical Development, 2005.
2. ICH Q9. Harmonised Tripartite Guideline Quality Risk Management, 2005.
3. van Dijk MA, Vidarsson G. Monoclonal antibody-based pharmaceuticals. In: Crommelin DJA, Sindelar RD, editors. Pharmaceutical Biotechnology. 2nd ed. London: Taylor&Francis; 2002. p 283-299.
4. Tague NR. The Quality Toolbox. 2nd ed. Milwaukee: ASQ Quality Press; 2004. p 247.