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Probability lower bounds for USP/NF tests.

Publication ,  Journal Article
Chow, S-C; Shao, J; Wang, H
Published in: J Biopharm Stat
February 2002

In the pharmaceutical industry, a number of tests such as content uniformity and dissolution testing are usually performed at various stages of drug manufacturing process to ensure that the drug product meets standards for identity, strength, quality, purity, and stability of the drug product as specified in the United States Pharmacopedia and National Formulary (USP/NF). The USP/NF provides requirements for sampling plans, testing procedures, and acceptance criteria for these tests. To ensure that there is a high probability of passing the USP/NF tests, the sponsors usually establish in-house specification limits based on some lower bounds of the probabilities of passing USP/NF tests for future samples. In this article, we derive some probability lower bounds for USP/NF tests. It is shown that the proposed probability lower bounds are better than the existing ones and are very close to the true probabilities in a broad range of the population mean and variance of the test sample.

Duke Scholars

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

February 2002

Volume

12

Issue

1

Start / End Page

79 / 92

Location

England

Related Subject Headings

  • Statistics & Probability
  • Solubility
  • Reference Standards
  • Quality Control
  • Probability
  • Pharmacopoeias as Topic
  • Pharmaceutical Preparations
  • Models, Statistical
  • Drug Compounding
  • 4905 Statistics
 

Citation

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Chow, S.-C., Shao, J., & Wang, H. (2002). Probability lower bounds for USP/NF tests. J Biopharm Stat, 12(1), 79–92. https://doi.org/10.1081/bip-120005781
Chow, Shein-Chung, Jun Shao, and Hansheng Wang. “Probability lower bounds for USP/NF tests.J Biopharm Stat 12, no. 1 (February 2002): 79–92. https://doi.org/10.1081/bip-120005781.
Chow S-C, Shao J, Wang H. Probability lower bounds for USP/NF tests. J Biopharm Stat. 2002 Feb;12(1):79–92.
Chow, Shein-Chung, et al. “Probability lower bounds for USP/NF tests.J Biopharm Stat, vol. 12, no. 1, Feb. 2002, pp. 79–92. Pubmed, doi:10.1081/bip-120005781.
Chow S-C, Shao J, Wang H. Probability lower bounds for USP/NF tests. J Biopharm Stat. 2002 Feb;12(1):79–92.
Journal cover image

Published In

J Biopharm Stat

DOI

ISSN

1054-3406

Publication Date

February 2002

Volume

12

Issue

1

Start / End Page

79 / 92

Location

England

Related Subject Headings

  • Statistics & Probability
  • Solubility
  • Reference Standards
  • Quality Control
  • Probability
  • Pharmacopoeias as Topic
  • Pharmaceutical Preparations
  • Models, Statistical
  • Drug Compounding
  • 4905 Statistics