Design and analysis of analytical method transfer studies

Journal of Biopharmaceutical Statistics

Volumn 18, Issue 5, 2008, Pages 1013-1033

  Schwenke, James R ^a   O'Connor, Dennis K ^a  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

Analytical validation; Analytical variability; Equivalence testing; Quality by design

Indexed keywords

ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; EXPERIMENTAL DESIGN; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; LABORATORY; METHOD TRANSFER; PRIORITY JOURNAL; QUALITY CONTROL; REPRODUCIBILITY; STATISTICAL ANALYSIS; STATISTICAL PARAMETERS; SYSTEM ANALYSIS; TECHNOLOGY; VALIDATION STUDY;

ANALYSIS OF VARIANCE; CHEMISTRY, ANALYTICAL; CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; LABORATORIES; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN;

EID: 51649088442     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400802287354     Document Type: Article

References (13)

1. Crawford, L. M., U.S. Food and Drug Administration. (2002). Pharmaceutical cGMPs Initiative. Food and Drug Administration (FDA) announcement. Washington, DC: FDA. www.fda.gov/oc/guidance/announce.html.
2. Food and Drug Administration, Center for Drug Evaluation and Research. (2004a). Pharmaceutical GMPs for the 21st Century - A Risked Based Approach, Final Report. Washington, DC: FDA. www.fda.gov/cder/gmp/gmp2004/ GMP_finalreport2004.htm.
3. Food and Drug Administration, Center for Drug Evaluation and Research. (2004b). PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance. Washington, DC: FDA. www.fda.gov/cder/guidance/6419fnl.pdf.
4. Food and Drug Administration, Center for Drug Evaluation and Research. (2006). Quality Systems Approach to Pharmaceutical cGMP Regulations. Washington, DC: FDA. www.fda.gov/cder/guidance/7260fnl.pdf.
5. International Conference on Harmonization Guideline (ICH). (2005a). Q8 (step 4), Pharmaceutical Development. www.ich.org/LOB/media/MEDIA1707.pdf.
6. International Conference on Harmonization Guideline (ICH). (2005b). Q9 (step 4), Quality Risk Management. www.ich.org/LOB/media/MEDIA1957.pdf.
7. ISPE. (2003). ISPE Good Practice Guide: Technology Transfer. Tampa, FL: ISPE.
8. Littell, R. C., Milliken, G. A., Stroup, W. W., Wolfinger, R. D., Schabenberger, O. (2006). SAS® for Mixed Models, Second Edition. Cary, NC: SAS Institute Inc.
9. Milliken, G. A., Johnson, D. E. (1992). Analysis of Messy Data, Volume I: Designed Experiments. Boca Raton, FL: Chapman and Hall/CRC.
10. Pharmaceutical Research and Manufacturers Association Analytical Research and Development Workshop, Wilmington, Delaware (2000).
11. Schuirmann, D. J. (1987). A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet Biopharmaceutics 15:657-680.
12. Scypinski, S., Roberts, D., Oates, M., Etse, J. (2004). Pharmaceutical Research and Manufacturers Association Acceptable Analytical Practice for Analytical Method Transfer. Pharm. Tech. 28:84-88.
13. Tougas, T. (2006). Considerations of the role of end product testing in assuring the quality of pharmaceutical products. Proc. Anal. Technol. 3:13-17.