The compliance and science of blend uniformity analysis

PDA Journal of Pharmaceutical Science and Technology

Volumn 55, Issue 4, 2001, Pages 209-222

  Berman, J ^a  

^a Bayer Consumer Care Division   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; DEVICE; DRUG INDUSTRY; ERROR; FOOD AND DRUG ADMINISTRATION; POWDER; REVIEW; SAMPLING; TABLET FORMULATION;

CHEMISTRY, PHARMACEUTICAL; DRUG INDUSTRY; EQUIPMENT AND SUPPLIES; TECHNOLOGY, PHARMACEUTICAL;

EID: 0034903737     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (40)

1. Preliminary investigations of the suitability of the USP uniformity of dosage units tests for evaluating the uniformity of powder blends and their corresponding tablets
2. Food and drug administration's recommendations of validation issues
3. 21 CFR parts 210 and 211, current good manufacturing practice: Amendment of certain requirements for finished pharmaceuticals; proposed rule
4. Blend uniformity and unit dose sampling
5. Examination of components of variance for a production scale, low-dose powder blend and resulting tablets
6. Unit dose sampling - A tale of two thieves
7. Unit-dose sampling and blend content uniformity testing
8. Comparison of the performance of two sample thieves for determination of the content uniformity of a powder blend
9. Sampling bias in blending validation and a different approach to homogeneity assessment
10. Evaluation of blend uniformity: Effect of granulation sample size
11. Evaluation of blend sampling errors: A statistical approach
12. Blending validation and content uniformity of low-content, noncohesive powder blends
13. An evaluation of a unit-dose compacting sample thief and a discussion of content uniformity testing and blending validation issues
14. The mixing of solids in tumbling mixers - I
15. Mixing powders to fine-scale homogeneity: Studies of batch mixing
16. The mixing of cohesive powders
17. Monitoring the mixing of powders
18. The definition and assessment of mixture quality in mixtures of particulate solids
19. Errors associated with the thief probe for bulk powder sampling
20. Assessing the homogeneity of an ordered mixture
21. Sampling practices in powder blending
22. An improved powder-sampling tool
23. A novel sample thief designed to avoid biased data
24. Sampling in blending validation
25. Is it necessary to take small blend samples to assess drug uniformity?
26. Blending validation of low drug content dosage forms
27. Blending validation of low drug content dosage forms
28. Technical report no. 25 blend uniformity analysis: Validation and in-process testing
29. A statistical approach to blend uniformity acceptance criteria
30. Constructing acceptance limits for multiple stage tests