Unit-dose sampling and blend content uniformity testing

Pharmaceutical Technology

Volumn 21, Issue 4, 1997, Pages 116-125

  Mohan, Sandhya ^a   Rankell, Albert ^c   Rehm, Carl ^c   Bhalani, Vin ^b   Kulkarni, Arun ^c  

^a Quality Assurance at Immunomedics   (United States)

^b Sidmak Laboratories   (United States)

^c Pharmax Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DOSE; GOOD MANUFACTURING PRACTICE; SAMPLING; SHORT SURVEY;

EID: 0030904834     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (10)

1. United States vs. Barr Laboratories, 812F. Sup 458 (District Court of New Jersey) 1993.
2. FDA, "Guide to Inspections of Oral Solid Dosage Forms Pre/Post-approval Issues for Development and Validation," January 1994.
3. L.M. Dietrick, "Food and Drug Administration Recommendations on Validation Issues," Regulatory Affairs 5, 363-366 (1993).
4. J. Berman and J.A. Planchard, "Blend Uniformity and Unit-Dose Sampling," Drug Dev. Ind. Pharm. 21 (11), 1257-1283 (1995).
5. J. T. Carstensen and M. V. Dali, "Blending Validation and Content Uniformity of Low-Content, Noncohesive Powder Blends," Drug Dev. Ind. Pharm. 22 (4), 285-290 (1996).
6. J. T. Carstensen, M. Dali, and M. Pudipeddi, "Blending Validation of Low Drug Content Dosage Forms," Pharm. Dev. Technol. 1(1), 113-114 (1996).
7. R.T. Lantz and J.B. Schwartz, "Mixing," in Pharmaceutical Dosage Forms, Tablets, Vol. 2, Lieberman, Lachman, and Schwartz, Eds. (Marcel Dekker, 2d ed., 1990).
8. Brian Kaye, "Sampling and Characterization Research: Developing Two Tools for Powder Testing," Powder Bulk Eng., February 1996.
9. T. Allen, Particle Size Measurement (Chapman and Hall, London, 2d ed., 1975).
10. J.K. Prescott and R.J. Hossfeld, "Maintaining Product Uniformity and Uninterrupted Flow to Direct-Compression Tableting Presses," Pharm. Technol. 18 (6), 99-114 (1994).