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Drug Development and Industrial Pharmacy Volume 25, 1999 - Issue 2
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Research Article

Sampling Bias in Blending Validation and a Different Approach to Homogeneity Assessment

Jeannette Kræmer
,
Jørgen Ryhl Svensson
&
Henrik Melgaard
Pages 217-222 | Published online: 25 Jan 1999

REFERENCES

  • Carstensen J. T., Dali M. Blending validation and content uniformity of low-content. noncohesive powder blends 1996; 21: 285–290
  • Carstensen J. T., Dali M., Pudipeddi M. Blending validation of low drug content dosage forms. Pharm. Dev. Tech. 1996; 1: 113–115
  • Carstensen J. T., Dali M., Pudipeddi M. Calculation of intensified sampling plans in blending validation. Pharm. Dev. Tech. 1997; 2: 87–89
  • Berman J., Planchard J. A. Blending uniformity and unit dose sampling. Drug Dev. Ind. Pharm. 1995; 21: 1257–1267
  • Berman J., Schoeneman A., Shelton J. T. Unit dose sampling: a tale of two thieves. Drug Dev. Ind. Pharm. 1996; 22: 1121–1132
  • Carstensen J. T., Rhodes C. T. Drug Dev. Ind. Pharm. 1993; 19: 2699–2708
  • Orr N. A., Shotton E. The mixing of cohesive powders. Chemical Eng. January 1973; 12–16
  • Chang R. K., Shukla J., Buehler J. An evaluation of a unit-dose compacting sample thief and a discussion of content uniformity testing and blending validation issues. Drug Dev. Ind. Pharm. 1996; 22: 1031–1035
  • Pinto I., Perez G., Wallace W. P. Unit dose bulk material sampling apparatus. U.S. Patent 5,479,017, December 19, 1995
  • Carstensen J. T. Pharmaceutical Principles of Solid Dosage Forms. Technomic Publishing, Lancaster, PA 1993; 24

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