Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment - Pharmaceutical Technology

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Overcoming Disincentives to Process Understanding in the Pharmaceutical CMC Environment
Larger and strategic sampling and testing plans can improve process understanding and characterization.


Pharmaceutical Technology


17. S. Ruberg and J. Hsu, "Multiple Comparison Procedures for Pooling Batches in Stability Studies," Technometrics 34 (4), 465–472 (1992).

18. IPAC–RS, "A Parametric Tolerance Interval Test for Improved Control of Delivered Dose Uniformity of Orally Inhaled and Nasal Drug Products" (2001), http:// http://ipacrs.com/PDFs/IPAC-RS_DDU_Proposal.PDF.

19. PQRI BUWG, "The Use of Stratified Sampling of Blend and Dosage Units to Demonstrate Adequacy of Mix for Powder Blends," PDA J. Pharm. Sci. Technol. 57 (2), 64 –74 (2003).

20. W. Hauck et al., "Oral Dosage Form Performance Tests: New Dissolution Approaches," Pharm. Res. 22 (2), 182–187 (2005).

21. R. Williams et al., "Content Uniformity and Dose Uniformity: Current Approaches, Statistical Approaches, and Presentation of an Alternative Approach, with Special Reference to Oral Inhalation and Nasal Drug Products," Pharm. Res. 19 (4), 359–366 (2002).


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