title: Two-stage sampling in pharmaceutical applications.
abstract: In 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.
authors.affiliation: Mathematics, University of Ottawa, Ontario, Canada.
authors.forename: J
authors.initials: J
authors.lastname: Shao
authors.forename: S C
authors.initials: SC
authors.lastname: Chow
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003277:Contraceptives, Oral, Combined / Q000008:administration & dosage; D003280:Contraceptives, Oral, Synthetic / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004341:Drug Evaluation / Q000706:statistics & numerical data*; D004345:Drug Industry; D004349:Drug Packaging / Q000706:statistics & numerical data; D004997:Ethinyl Estradiol / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008422:Materials Testing / Q000706:statistics & numerical data; D015337:Multicenter Studies as Topic / Q000706:statistics & numerical data*; D009640:Norethindrone / Q000008:administration & dosage; D011785:Quality Assurance, Health Care / Q000706:statistics & numerical data*; D011786:Quality Control
chemical_list: D003277:Contraceptives, Oral, Combined; D003280:Contraceptives, Oral, Synthetic; D004338:Drug Combinations; C020416:norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination; D004997:Ethinyl Estradiol; D009640:Norethindrone