Public comment period · §3
Draft monograph: KPV — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-KPV-MONOGRAP/001 | Dr Leonhard Quenneville | The document should state what a reader ought to do | Not accepted |
| DRAFT-KPV-MONOGRAP/002 | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-KPV-MONOGRAP/003 | Dr Xenia Nyquist-Obiora | The route of administration studied is not the route in which the compound is supplied | Accepted |
| DRAFT-KPV-MONOGRAP/004 | Dr Zdenka Nyquist-Obiora | The mechanism section is written with more confidence than the clinical section it precedes | Accepted in part |
| DRAFT-KPV-MONOGRAP/005 | Dr Fenella Steenkamp-Ferreira | The interaction section lists mechanisms rather than interactions | Accepted in part |
| DRAFT-KPV-MONOGRAP/006 | Dr Odalys Thorsby-Nakamura | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-KPV-MONOGRAP/007 | Dr Gervase Abergavenny | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-KPV-MONOGRAP/008 | Dr Georgiana Mountstephen | The document set should be published in translation | Not accepted |
| DRAFT-KPV-MONOGRAP/009 | Dr Melisande Kirkpatrick-Ola | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-KPV-MONOGRAP/010 | Anselm Mountstephen | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-KPV-MONOGRAP/011 | Dr Henrike Jastrzębska | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-KPV-MONOGRAP/012 | Dr Quentin Zimmerthal | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-KPV-MONOGRAP/013 | Dr Xiomara Fairweather-Duru | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-KPV-MONOGRAP/014 | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-KPV-MONOGRAP/015 | Bertrand Ollerenshaw industry | The document should not describe uses outside the approved indication | Not accepted |
| 15 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 8 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 3 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 3 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-KPV-MONOGRAP/002. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.
- The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-KPV-MONOGRAP/003. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
- The mechanism section is written with more confidence than the clinical section it precedes — arising from DRAFT-KPV-MONOGRAP/004. Every pharmacology section now closes with a statement identifying which described actions are supported by clinical evidence assessed in §3 and which are not. The pharmacology itself is stated as the sources state it.
- The interaction section lists mechanisms rather than interactions — arising from DRAFT-KPV-MONOGRAP/005. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-KPV-MONOGRAP/006. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-KPV-MONOGRAP/007. Mechanistic claims not traceable to a primary source are removed, and those retained carry their source and a statement of whether the underlying work was conducted in vitro, in animals or in humans.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-KPV-MONOGRAP/009. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-KPV-MONOGRAP/011. The analytical section is reduced to compound-specific content and cross-references the relevant standards for the general procedure, which shortens it substantially without removing what is not available elsewhere.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-KPV-MONOGRAP/012. Purity and content are now reported in separate rows with separate definitions, and the monograph states that a purity figure sets no bound on content and that a content figure requires a determination against a standard of assigned content.
- What happens when the compound is stopped is not addressed — arising from DRAFT-KPV-MONOGRAP/013. Discontinuation trajectory is now an assessed outcome in every monograph where a contributing trial measured it, and a recorded evidence gap in every monograph where none did, so that its absence is visible rather than silent.
- The compound is supplied under names the monograph does not list — arising from DRAFT-KPV-MONOGRAP/014. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.
Compound Evidence Institute · CEI-CP-059/3 · https://compoundevidence.com/comment-periods/draft-kpv-monograph/disposition/ · retrieved 30 July 2026