Document Detail

Assessing parallelism prior to determining relative potency.
MedLine Citation:
PMID:  15971545     Owner:  NLM     Status:  MEDLINE    
In the course of preparing a revision to Chapter (111) of the U.S. Pharmacopeia, the revision committee came to a unanimous agreement that the method for assessing parallelism that is currently presented in (111) and in the European Pharmacopeia's Chapter 5.3 is flawed and should be replaced. The symptoms are that perfectly acceptable assay results may fail due to good precision and that obviously faulty assay results may pass due to poor precision. The flaw is that the wrong statistical technique has been used. We propose an alternative approach based on the equivalence testing paradigm that does not have these shortcomings. Equivalence testing requires the establishment of equivalence limits. Specific approaches for establishing equivalence limits are discussed.
Walter W Hauck; Robert C Capen; Janice D Callahan; James E De Muth; Henry Hsu; David Lansky; Nancy C Sajjadi; Sally S Seaver; Robert R Singer; Doris Weisman
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  PDA journal of pharmaceutical science and technology / PDA     Volume:  59     ISSN:  1079-7440     ISO Abbreviation:  PDA J Pharm Sci Technol     Publication Date:    2005 Mar-Apr
Date Detail:
Created Date:  2005-06-23     Completed Date:  2006-07-27     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9439538     Medline TA:  PDA J Pharm Sci Technol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  127-37     Citation Subset:  IM    
Biostatistics Section, Thomas Jefferson University, 211 S. Ninth St., #602, Philadelphia, PA 19107, USA.
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MeSH Terms
Data Interpretation, Statistical*
Pharmaceutical Preparations / metabolism
Pharmacopoeias as Topic / standards*
Reproducibility of Results
Technology, Pharmaceutical / methods,  standards,  statistics & numerical data
Therapeutic Equivalency
Reg. No./Substance:
0/Pharmaceutical Preparations

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