Public comment period · §3
Draft monograph: Lixisenatide — 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-LIXISENATIDE/001 | Dr Quentin Zimmerthal | The monograph does not tell a reader that two vials of the same compound may not contain the same thing | Accepted |
| DRAFT-LIXISENATIDE/002 | Dr Hortensia Hollingworth | Anti-drug antibody data are omitted | Accepted in part |
| DRAFT-LIXISENATIDE/003 | Dr Lorcan Trelawney | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-LIXISENATIDE/004 | Dr Quentin Enthoven | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| DRAFT-LIXISENATIDE/005 | Dr Nikolai Yeovil-Bakare | A near-isobaric analogue is not distinguished by the identity determination described | Accepted |
| DRAFT-LIXISENATIDE/006 | Dr Vittoria Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-LIXISENATIDE/007 | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval | Accepted in part |
| DRAFT-LIXISENATIDE/008 | Dr Leonhard Quenneville | The preclinical section is extensive and the clinical section is not | Accepted in part |
| DRAFT-LIXISENATIDE/009 | Dr Wolfram Quintanilha industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-LIXISENATIDE/010 | Dr Nadezhda Lavrentiev | What happens to weight after the compound is stopped is not in the assessed outcomes | Accepted |
| 10 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 | 4 | 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
- The monograph does not tell a reader that two vials of the same compound may not contain the same… — arising from DRAFT-LIXISENATIDE/001. A standing paragraph now appears at the head of §8 in every monograph, stating that a determination applies to the lot measured and that a label mass is not a determination.
- Anti-drug antibody data are omitted — arising from DRAFT-LIXISENATIDE/002. Anti-drug antibody incidence and any reported association with loss of effect are now reported where measured, and recorded as not measured where the contributing trials did not assess them.
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-LIXISENATIDE/003. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
- The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-LIXISENATIDE/004. 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.
- A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-LIXISENATIDE/005. 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.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-LIXISENATIDE/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…
- Point estimates are given without an interval — arising from DRAFT-LIXISENATIDE/007. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
- The preclinical section is extensive and the clinical section is not — arising from DRAFT-LIXISENATIDE/008. The preclinical section is reduced in length, placed after the clinical assessment rather than before it, and opens with a standing statement that an effect observed in an animal model is not a clinical outcome and does not support a certainty rating.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-LIXISENATIDE/009. 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.
- What happens to weight after the compound is stopped is not in the assessed outcomes — arising from DRAFT-LIXISENATIDE/010. Post-withdrawal trajectory is now an assessed outcome wherever a withdrawal period was studied, rated on the same scale as the others. Where no withdrawal period was studied the outcome is recorded as not assessed.
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-062/3 · https://compoundevidence.com/comment-periods/draft-lixisenatide-monograph/disposition/ · retrieved 30 July 2026