REFERENCES
- Berman J., Planchard J. A. Blend uniformity and unit dose sampling. Drug Dev. Ind. Pharm. 1995; 21(11)1257–1283
- Harwood C. F., Walanski K. A. Monitoring the mixing of powders. ACS Div. Org. Coatings Plastic Chem. 1973; 33(2)508–515
- Schofield C. The definition and assessment of mixture quality in mixtures of particulate solids. Powder Technol. 1976; 15: 169–180
- Muzzio F., Robinson P., Wightman C., Brone D. Sampling practices in powder blending. Int. J. Pharm. 1997; 155: 153–178
- Lantz R. L., Jr., Schwartz J. B. Pharmaceutical Dosage Forms—Tablets, H. A. Liebermann, L. Lachman, J. B. Schwartz. 2nd Ed., Marcel Dekker, New York 1989; 2: 27–32
- Harwood C. F., Ripley T. Errors associated with the thief probe for bulk powder sampling. J. Powder Bulk Solids Technol. 1977; 11: 20–29
- Berman J., Schoeneman A., Shelton J. T. Unit dose sampling—a tale of two thieves. Drug Dev. Ind. Pharm. 1996; 22(11)1121–1132
- Garcia T., Elsheimer B., Tarczynski F. Examination of components of variance for a production scale, low dose powder blend and resulting tablets. Drug Dev. Ind. Pharm. 1995; 21(18)2035–2045
- Garcia T., Taylor M., Pande G. Comparison of the performance of two sample thieves for the determination of the content uniformity of a powder blend. Pharm. Dev. Technol. 1998; 3(1)7–12
- Carstensen J. T., Dali M. V. Blending validation and content uniformity of low-content, noncohesive powder blend. Drug Dev. Ind. Pharm. 1996; 22(4)285–290
- Blend uniformity analysis: validation and in-process testing, Technical Report No. 25. PDA J. Pharm. Sci. Technol. 1997; 51(S3)
- Guidance for Industry, ANDAs: Blend Uniformity Analysis. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). August 1999, OGD
- Mohan S., Rankell A., Rehm C., Bhalani V., Kukarni A. Unit dose sampling and blend content uniformity testing. Pharm. Technol. April 1997; 116–125
- Carstensen J. T., Rhodes C. T. Sampling in blending validation. Drug Dev. Ind. Pharm. 1993; 19(20)2699–2708
- Tanino T., Yoshida T., Sumi Y., Ohtani S., Mizuta T. Evaluation of blend uniformity: effect of granulation sample size. J. Jpn. Soc. Pharm. Mach. Eng. 1999; 8: 5–14