TWO‐stage sampling in pharmaceutical applications
Copyright policy )TWO‐stage sampling in pharmaceutical applications
AbstractIn the pharmaceutical industry, some tests for quality assurance before, during and after the manufacture of a drug product involve a two‐stage sampling technique. We propose statistical testing procedures in a two‐stage sampling problem with large within‐class sample sizes. We also derive a two‐stage sampling plan by minimizing the expected squared volume )or the generalized variance( of the confidence region related to the test. We present two examples to illustrate the proposed methods.
- University of Ottawa Canada
- Bristol-Myers Squibb (Germany) Germany
Quality Control, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Industry, Quality Assurance, Health Care, Ethinyl Estradiol, Contraceptives, Oral, Synthetic, Contraceptives, Oral, Combined, Drug Combinations, Materials Testing, Drug Evaluation, Humans, Multicenter Studies as Topic, Female, Norethindrone, Drug Packaging
Quality Control, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Industry, Quality Assurance, Health Care, Ethinyl Estradiol, Contraceptives, Oral, Synthetic, Contraceptives, Oral, Combined, Drug Combinations, Materials Testing, Drug Evaluation, Humans, Multicenter Studies as Topic, Female, Norethindrone, Drug Packaging
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