Public comment period · §3
Draft monograph: Liraglutide — 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-LIRAGLUTIDE-/001 | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-LIRAGLUTIDE-/002 | Dr Liesbeth Zaleski-Mbeki | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-LIRAGLUTIDE-/003 | Dr Ottoline Fitzgerald-Nwosu | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-LIRAGLUTIDE-/004 | Dr Jacinta Grünbaum-Sowande | Glycaemic trials and weight-management trials are drawn on interchangeably | Accepted |
| DRAFT-LIRAGLUTIDE-/005 | Dr Matthias Wintringham industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-LIRAGLUTIDE-/006 | Dr Ndidi Ravensworth-Ilunga | Open-label extension data are presented alongside randomised data without distinction | Accepted |
| DRAFT-LIRAGLUTIDE-/007 | Dr Lorcan Whitmarsh-Obi | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-LIRAGLUTIDE-/008 | Vittoria Ylönen | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| 8 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 6 | 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 | 0 | 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 | 0 | 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
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-LIRAGLUTIDE-/001. 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.
- The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-LIRAGLUTIDE-/002. 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.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-LIRAGLUTIDE-/003. 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.
- Glycaemic trials and weight-management trials are drawn on interchangeably — arising from DRAFT-LIRAGLUTIDE-/004. Every effect estimate now names its programme, and the assessed-outcome table is split where a compound has more than one.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-LIRAGLUTIDE-/005. The approved indication and contraindications are now reproduced verbatim from the named authorisation with its version and date, and the posology section reports the labelled schedule and the schedules studied side by side, with the source of each stated.
- Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-LIRAGLUTIDE-/006. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-LIRAGLUTIDE-/007. 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.
- The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-LIRAGLUTIDE-/008. Every headline estimate now carries a one-line statement of the population in which it was observed, and the full eligibility criteria are reported in the included-studies table rather than only in the source.
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-061/3 · https://compoundevidence.com/comment-periods/draft-liraglutide-monograph/disposition/ · retrieved 30 July 2026