Acceptable, equivalent, or better: Approaches for alternatives to official compendia! procedures

Pharmacopeial Forum

Volumn 35, Issue 3, 2009, Pages 772-778

  Hauck, W W ^a   DeStefano, A J ^b   Cecil, T L ^b   Abernethy, D R ^b   Koch, W F ^b   Williams, R L ^b  

^a US Pharmacopeia   (United States)

^b US Pharmacopeial Convention ^*  (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTIC METHOD; BIOEQUIVALENCE; DRUG QUALITY; MEDICAL LITERATURE; PHARMACOLOGICAL EQUIVALENCE; REVIEW; UNITED STATES; VALIDATION PROCESS;

EID: 67649359953     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Review

References (13)

1. USPC. USP 31-NF 26, General Notices. Rockville, MD: USPC; 2008:7.
2. Joint Committee for Guides in Metrology. International Vocabulary of Metrology Basic and General Concepts and Associated Terms (VIM). 3rd ed. Geneva, Switzerland: ISO; 2007:2.6.
3. USPC. USP 32-NF 27, General Notices. Rockville, MD: USPC; 2009:6.
4. 21 CFR610.9(c).
5. FDA. Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. Rockville, MD: FDA; 2000:3-4. Available at: www.fda.gov/cber/ gdlns/methval.htm; accessed December 17, 2008.
6. ICH. Q6A, Specifications for New Drug Substances and Products, 2.7 Alternative Procedures. Geneva, Switzerland: ICH; 1999. Available at: www.ich.org/cache/compo/276-254-1 .html, accessed December 17, 2008.
7. Williams RL, Chen ML, Hauck WW. Equivalence approaches. Clin Pharmacol Ther. 2002;72(3):229-237.
8. Horowitz W. Nomenclature of interlaboratory analytical studies. Pure Appl Chem. 199;66:1903-1911.
9. Small Molecules Collaborative Group and USPC Staff. Per-formance-based Monographs. Pharm Forum. 2009;35(3):765-771.
10. Limentani GB, Ringo MC, Ye F, Bergquist ML, McSorley EO. Beyond the t-test: statistical equivalence testing. Anal Chem. 2005;77(11 ):221 A-226A.
11. Chambers D, Kelly G, Limentani G, Lister A, Lung KR, Warner E. Analytical method equivalency: an acceptable analytical practice. Pharm Technol. 2005;29(9):64-80.
12. Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing equivalence of average bioavailability. / Pharmacokinet Biopharma-ceutics. 1987,16:657-680.
13. Wellek S. Testing Statistical Hypotheses of Equivalence. New York: Chapman & Hall/CRC; 2003.