Dissolution test acceptance sampling plans

Journal of Biopharmaceutical Statistics
Yi TsongT E Ong

Abstract

The U.S. Pharmacopeia (USP) general monograph provides a standard for dissolution compliance with the requirements as stated in the individual USP monograph for a tablet or capsule dosage form. The acceptance rules recommended by USP have important roles in the quality control process. The USP rules and their modifications are often used as an industrial lot release sampling plan, where a lot is accepted when the tablets or capsules sampled are accepted as proof of compliance with the requirement. In this paper, the operating characteristics of the USP acceptance rules are reviewed and compared to a selected modification. The operating characteristics curves show that the USP acceptance rules are sensitive to the true mean dissolution and do not reject a lot or batch that has a large percentage of tablets that dissolve with less than the dissolution specification.

References

Dec 1, 1971·Journal of Pharmaceutical Sciences·S Bisaillon, R Tawashi

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Citations

Mar 24, 2005·Pharmaceutical Research·Walter W HauckRoger L Williams
Apr 21, 1998·Journal of Biopharmaceutical Statistics·R A DeMasiC F Shih
Apr 9, 2008·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Rubén M MaggioTeodoro S Kaufman
Oct 31, 2014·Journal of Biopharmaceutical Statistics·Steven NovickStan Altan
Mar 24, 2007·Journal of Pharmaceutical and Biomedical Analysis·Monica L DumontBeverly Nickerson
Oct 8, 2004·Journal of Biopharmaceutical Statistics·Yi TsongVinod P Shah
Jul 31, 2002·Journal of Biopharmaceutical Statistics·Shein-Chung ChowHansheng Wang
Nov 27, 2002·Journal of Biopharmaceutical Statistics·Shein-Chung Chow, Jun Shao

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