A Proposed Content-Uniformity Test for Large Sample Sizes - Pharmaceutical Technology

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A Proposed Content-Uniformity Test for Large Sample Sizes
The authors describe a modified version of the Large-N test used to determine content uniformity.


Pharmaceutical Technology
pp. 72-79

Acknowledgment

The authors wish to thank Fasheng Li, associate director of statistics–Groton at Pfizer (New York) for creating the plots used in the paper. Thank you to Tom Garcia, a research fellow for global regulatory CMC–Groton at Pfizer and Ambarish Singh, associate director of global regulatory sciences–CMC at Bristol-Myers Squibb (New York) for reviewing the paper.

James Bergum* is an associate director of nonclinical biostatistics at Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08903, tel. 732.227.5981, fax 732.227.3005,
. Kim Erland Vukovinsky is a director of nonclinical statistics at Pfizer.

*To whom all correspondence should be addressed.

Submitted: Mar. 15, 2010. Accepted: Apr. 12, 2010.

References

1. USP 33–NF 28 Reissue, General Chapter <905>, "Uniformity of Dosage Units," (US Pharmacopeial Convention, Rockville, MD, Oct. 2010, pp. R–86).

2. D. Sandell, et al., Drug Info. J., 40, 337–344 (2006).


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