Commentary

Commentary— Revision proposals published in Pharmacopeial Forumoften elicit public comments that are forwarded to the appropriate Expert Committee for review and response.Some revision proposals can advance to official status with minor modifications,as needed,without requiring further public review.In such cases a summary of comments received and the Committee’s responses are published in the Commentarysection of the Supplementor annual edition in which the revision becomes official.For those proposals that require further revision and republication in Pharmacopeial Forum,a summary of the comments and the Committee’s responses will be included in the briefing that accompanies each article.
The Commentarysection is not part of the official text of the monograph.Rather,it explains the basis of the Committee’s response to public comments.If there is a difference between the contents of the Commentarysection and the official monograph,the text of the official monograph prevails.In case of dispute or question of interpretation,the language of the official text,alone and independent of the Commentarysection,shall prevail.
Where appropriate,the Commentary section includes a separate discussion of proposals related to international harmonization of the USP,the European Pharmacopoeia,and the Japanese Pharmacopoeiain order to highlight such proposals.
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MONOGRAPH COMMENTARY FORUSP28–NF23
The following revisions are slated to become official on January 1,2005.

Analytical Data—Interpretation and Treatment á1010ñ (page 2516of USP28–NF23).USPproposed this new General Information Chapter to provide guidance to the nonstatistician scientist on the use of the basic statistical methods found within.
Anumber of comments were received in response to the publication of the proposed General Information Chapter and this document addresses them.

    Reference:PF30(1)[Jan.–Feb.2004],page 236.
    Comment 1:This comment questioned the appropriateness of presenting the proposed chapter in USP.
    Response:The Biostatistics Expert Committee believes that the ready access to the information in the chapter within the book will be of great benefit to readers within the United States as well as among the many other countries that view the USP–NFas a valued source of information and standards.
    Comment 2:Replace the word “article”with “population”because article is not a standard statistical term.
    Response:The Committee agreed that the information given would apply to a broader category than is indicated by the compendial terminology,article,and therefore the term,population,is used.
    Comment 3:Under Outlying Results,the statement that resampling should be a rare event should be removed because it is not discussed in depth,and as a technique does not have validity in all situations.
    Response:The Committee agreed that discussion of the topic in appropriate depth would be outside of the intended scope of this chapter and therefore the sentence is deleted from the chapter.
    Comment 4:Introduce the reader to other statistical process control methods in addition to the moving range in the text for Appendix A.
    Response:Mention is made of the cumulative sum and exponentially weighted moving average methods.
    Comment 5:Provide background references for the two approximations of RSDfor log transformed data presented in Footnote 2.
    Response:The Committee may decide to provide a discussion of these concepts in a future publication but did not choose to elaborate in the current chapter.
    Comment 6:Appendix C,Dixon-Type Tests,the value for r11,0.05given,0.477,should be considered as a 10%critical value (rather than 5%)unless a predetermination had been made that outliers in one or the other direction,high or low,were either impossible or able to be ignored.
    Response:The Committee determined that 0.534is the appropriate r11,0.05value at the 5%significance level for a two-sided Dixon's Test.Rorabacher D.B.,Analytical Chemistry,1991:63(2):139–146in the list of references under Outlier Tests has a discussion on this topic.