Public comment period · §3
Draft monograph: semaglutide, version 3 — 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-SEMAGLUTIDE-/001 | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described | Accepted |
| DRAFT-SEMAGLUTIDE-/002 | Dr Lorcan Zaleski-Mbeki | Local reactions are omitted from the adverse-event table because the trials reported them separately | Accepted |
| DRAFT-SEMAGLUTIDE-/003 | Dr Fenella Lavrentiev | Glycaemic trials and weight-management trials are drawn on interchangeably | Accepted |
| DRAFT-SEMAGLUTIDE-/004 | Dr Leonhard Quenneville | The document should state what a reader ought to do | Not accepted |
| DRAFT-SEMAGLUTIDE-/005 | Dr Delphine Trelawney | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-SEMAGLUTIDE-/006 | Dr Quentin Zimmerthal | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-SEMAGLUTIDE-/007 | Dr Ludmila Tollemache | The monograph should state what the compound costs | Not accepted |
| DRAFT-SEMAGLUTIDE-/008 | Quentin Whitmarsh-Obi | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-SEMAGLUTIDE-/009 | Vittoria Ylönen | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-SEMAGLUTIDE-/010 | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-SEMAGLUTIDE-/011 | Dr Yusuf Whitmarsh-Obi | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-SEMAGLUTIDE-/012 | Dr Henrike Jastrzębska | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-SEMAGLUTIDE-/013 | Dr Vittoria Quintanilha | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-SEMAGLUTIDE-/014 | Dr Marisol Dunmore-Ekpo | Open-label extension data are presented alongside randomised data without distinction | Accepted |
| 14 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 9 | 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 | 2 | 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 | 2 | 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
- A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-SEMAGLUTIDE-/001. The analytical section now states the resolving power required to discriminate the pair, names the pair explicitly, and records that an identity claim made below that resolution is not conformant with the identity standard.
- Local reactions are omitted from the adverse-event table because the trials reported them separately — arising from DRAFT-SEMAGLUTIDE-/002. Local reactions are now carried in the adverse-event table wherever the source trials report them, footnoted with the convention each trial used.
- Glycaemic trials and weight-management trials are drawn on interchangeably — arising from DRAFT-SEMAGLUTIDE-/003. Every effect estimate now names its programme, and the assessed-outcome table is split where a compound has more than one.
- The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-SEMAGLUTIDE-/005. The pharmacokinetic section now states approximate time to steady state alongside the half-life and dosing interval, with the assumption of first-order elimination stated, and records where the assumption is not supported for this compound.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-SEMAGLUTIDE-/006. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
- References should carry a persistent identifier for every cited source — arising from DRAFT-SEMAGLUTIDE-/008. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SEMAGLUTIDE-/010. 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.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-SEMAGLUTIDE-/011. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-SEMAGLUTIDE-/012. 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.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-SEMAGLUTIDE-/013. 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.
- Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-SEMAGLUTIDE-/014. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
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-005/3 · https://compoundevidence.com/comment-periods/draft-semaglutide-monograph-v3/disposition/ · retrieved 30 July 2026