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Probability lower bounds for USP/NF tests
2002
Journal of Biopharmaceutical Statistics
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
doi:10.1081/bip-120005781
pmid:12146721
fatcat:maxxjrdcanhu3gnidyofwm7egi