The square root of N plus one sampling rule: How much confidence do we have?

Pharmaceutical Technology

Volumn 27, Issue 5, 2003, Pages 50-62

  Saranadasa, Hewa ^a  

^a Ortho McNeil Pharmaceutical Incorporated   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

MANUFACTURE; PLANNING; SAMPLING;

INADEQUACIES;

DRUG PRODUCTS;

ACCURACY; CALCULATION; GEOMETRY; MATHEMATICAL ANALYSIS; PHARMACEUTICS; POPULATION SIZE; QUALITY CONTROL; REVIEW; SAMPLE SIZE; SAMPLING; SIMULATION;

EID: 0041319312     PISSN: 15432521     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (18)

1. F.F. Stephan, "History of the Uses of Modern Sampling Procedures," J. Amer. Statist. Assoc. 43, 12-39 (1948).
2. M.H. Hansen, "Some History and Reminiscences on Survey Sampling," Statist. Sci. 2, 180-190 (1987).
3. D. Bellhouse, "A Brief History of Survey Sampling," in Handbook Of Statistics, P.R. Krishnaiah and C.R. Rao, Ed. (North-Holland, Amesterdam, 1988), pp. 1-15.
4. A.J. Izenman, "Statistical and Legal Aspect of the Forensic Study of Illicit Drugs," Satist. Sci. 16, 1, 35-57 (2001).
5. F.C. Blanck, "Report of the Committee on Sampling," J. Assoc. Official Agricultural Chemists 10, 92-98 (1927).
6. A.E. Paul, "Sampling Drugs", J. Assoc. Official Agricultural Chemists 10, 99-102 (1927).
7. H. Runkel, "Report on Methods for Sampling Flour", J. Assoc. Official Agricultural Chemists 9, 423-426 (1926).
8. J.C. Munch and G.L. Bidwell, "What Constitutes an Adequate Sample?" J. Assoc. Official Agricultural Chemists, 11, 220-222 (1928).
9. F.W. Quackenbush and R.C. Rund, "The Continuing Problem of Sampling", J. Assoc. Official Analytical Chemists 50, 997-1006 (1967).
10. E.M. Foster, "The Control of Salmonellae in Processed Foods: Classification Systems and Sampling Plan," J. Assoc. Official Analytical Chemists 54, 259-266 (1971).
11. K. Borland, "The Fallacy of Square Root Sampling Rule," J. Amer. Pharm. Assoc. 39 (7), 373-377 (1950).
12. United Nations, Recommended Method for Testing Cannabis: Manual for Use by National Narcotics Laboratories (United Nations, Division of Narcotic Drugs, Vienna, 1987).
13. DPSC Standards for the Manufacture and Packaging of Drugs, Pharmaceuticals and Biological Products (Defense Personnel Support Center, Philadelphia, PA, 1968).
14. Office of Regulatory Affairs, FDA Investigation Operations Manual, Chapter 4, Subsection 427.2, www.fda.gov/ora/inspect_ref/iom/ChapterText/420_part2.html (2002).
15. ANSI/ASQC Z1.4, Sampling Procedures and Tables for Inspection by Attributes (American Society for Quality Control, Milwaukee, WI, 1993).
16. W.G. Cochran, Sampling Techniques (Wiley Interscience, New York, NY, 3d ed., 1977).
17. R.A. Sugden, T.M.F. Smith, and R.P. Jones, "Cochran's Rule for Simple Random Sampling," J.R. Statist. Soc. B. 62 (4), 787-793 (2000).
18. R.A. Sugden and T.M.F. Smith, "Edgeworth Approximations to the Distribution of the Sample Mean Under Simple Random Sampling," Statistics & Probability Letters 34, 293-299 (1997).