Think strategically for design of experiments success

BioProcess International

Volumn 9, Issue 3, 2011, Pages 18-25

  Snee, Ronald D ^a  

^a Snee Associates LLC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CONCEPTUAL FRAMEWORK; DATA ANALYSIS; DRUG INDUSTRY; ENVIRONMENTAL FACTOR; EXPERIMENTAL DESIGN; EXPERIMENTAL MODEL; INFORMATION RETRIEVAL; PROCESS DESIGN; PROCESS OPTIMIZATION; PRODUCT DEVELOPMENT; REPRODUCIBILITY; SHORT SURVEY; STATISTICAL ANALYSIS; STRATEGIC PLANNING;

EID: 79952638619     PISSN: 15426319     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Short Survey

References (14)

1. Snee RD. Quality by Design - Four Years and Three Myths Later. Pharm. Process. February 2009: 14-16. www.pharmpro.com/articles/2010/03/government-and- regulatory-Implementing-Quality-by-Design.
2. Snee RD. Building a Framework for Quality by Design. Pharm. Technol. online, October 2009, http://pharmtech.findpharma.com/pharmtech/ Special+Section%3a+Quality+by+Design/Building-a-Framework-for-Quality-by-Design/ ArticleStandard/Article/detail/632988?ref=25.
3. Snee RD. Robust Strategies for Improving Upstream Productivity. BioPharm Int. 23(6) 2010: S28-S33.
4. ICH Q8. Harmonized Tripartite Guideline: Pharmaceutical Development. Current Step 4 Version. International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use: Geneva, Switzerland, 10 November 2005.
5. Juran JM. Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. The Free Press, New York, NY 1992.
6. Lonardo A, Snee RD, and Qi B. Time Value of Information in Design of Downstream Purification Processes - Getting the Right Data in the Right Amount at the Right Time. BioPharm Intl. 23(3) 2010: 23-28.
7. Snee RD. Raising Your Batting Average: Remember the Importance of Strategy in Experimentation. Quality Progress December 2009: 64-68.
8. Yan L, Le-he M. Optimization of Fermentation Conditions for P450 BM-3 Monooxygenase Production by Hybrid Design Methodology. J. Zhejian University Science B 8(1): 27-32.
9. Hulbert MH, et al. Risk Management in Pharmaceutical Product Development: White Paper Prepared by the PhRMA Drug Product Technology Group. J. Pharm. Innovation 3, 2008: 227-248.
10. Schweitzer M, et al. Implications and Opportunities of Applying QbD Principles to Analytical Measurements. Pharm. Technol. 33 (2) 2010, 52-59
11. Box GEP, Hunter JS, and Hunter WG. Statistics for Experimenters - Design, Innovation, and Discovery. Wiley-Interscience: New York, NY, 2005.
12. Montgomery DA. Design and Analysis of Experiments, 7th Edition. John Wiley and Sons: New York, NY, 2005.
13. Snee RD. Computer-Aided Design of Experiments: Some Practical Experiences. J. Quality Technol. 17(4) 1985; 222-236
14. Hoerl RW, Snee RD. Statistical Thinking: Improving Business Performance, Duxbury Press: Pacific Grove, CA, 2002.