RT Journal Article
SR Electronic
T1 Assessing Parallelism Prior to Determining Relative Potency
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 127
OP 137
VO 59
IS 2
A1 Walter W. Hauck
A1 Robert C. Capen
A1 Janice D. Callahan
A1 James E. De Muth
A1 Henry Hsu
A1 David Lansky
A1 Nancy C. Sajjadi
A1 Sally S. Seaver
A1 Robert R. Singer
A1 Doris Weisman
YR 2005
UL http://journal.pda.org/content/59/2/127.abstract
AB In the course of preparing a revision to Chapter 〈111〉 of the US 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.