Method transfer from R&D to quality control of an RP-IPC method with ELSD for the analysis of an excipient in a pharmaceutical drug product

American Laboratory

Volumn 37, Issue 24, 2005, Pages 9-14

  Rodríguez, Shirley A ^a   Kubiak, René ^a   Mulcey, Michael ^a   Tamblyn, Toby ^a   Tougas, Terrence ^a  

^a BOEHRINGER INGELHEIM PHARMACEUTICALS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 33744830863     PISSN: 00447749     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (6)

1. Cannon JB. Oral solid dosage forms of lipid-based drug delivery systems. Am Pharm Rev 2005;8(1):108-15.
2. Rodríguez SA, Mulcey M, Tamblyn T. Development and validation of an RPIPC method with ELSD for the assay of ions and an excipient in a self-emulsifying drug delivery system formulation, Am Lab Oct 2005; 37(10):9-14.
3. Miller JM, Crowther JB. Analytical chemistry in a GMP environment: a practical guide. New York: John Wiley & Sons, Inc., 2000.
4. Owen DB. A special case of bivariate non-central t-distribution. Biometrika 1965; 52: 437-46.
5. Diletti E, tiauschke D, Steinijans VW. Sample size determination for bioequwa-lence assessment by means of confidence intervals, Int J Clin Pharm Ther Tax 1991; 29(1): 1-8.
6. Schuirmann DJ. A comparison of the two-one-sided-tests-procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 1987; 15(6).657-80.