Public comment period · §3
Draft monograph: Larazotide acetate — 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-LARAZOTIDE-M/001 | Dr Jolanta Uttridge | The route of administration studied is not the route in which the compound is supplied | Accepted |
| DRAFT-LARAZOTIDE-M/002 | Dr Eamon Immelmann | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water | Accepted |
| DRAFT-LARAZOTIDE-M/003 | Anselm Mountstephen | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-LARAZOTIDE-M/004 | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-LARAZOTIDE-M/005 | Dr Ivo Quintanilha | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| DRAFT-LARAZOTIDE-M/006 | Dr Valentin Castellanos-Reid | The absence of paediatric evidence is not stated where a reader would look for it | Accepted |
| DRAFT-LARAZOTIDE-M/007 | Dr Hyacinth Drakeford-Amadi | The interaction section lists mechanisms rather than interactions | Accepted in part |
| DRAFT-LARAZOTIDE-M/008 | Dr Melisande Kirkpatrick-Ola | Every contributing trial shares one sponsor and the monograph does not say so | 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 | 1 | 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 | 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 route of administration studied is not the route in which the compound is supplied — arising from DRAFT-LARAZOTIDE-M/001. 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 monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-LARAZOTIDE-M/002. The monograph now states, at the point where vial contents are first mentioned, that a mass figure is uninterpretable unless it states whether it is peptide content or total solids, and cross-references the content standard in the analytical series.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-LARAZOTIDE-M/004. 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.
- The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-LARAZOTIDE-M/005. Each assessed outcome now carries its downgrade domains in the summary-of-findings row, with a short statement of the judgement made in each, so that the rating can be checked domain by domain against the contributing trials.
- The absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-LARAZOTIDE-M/006. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
- The interaction section lists mechanisms rather than interactions — arising from DRAFT-LARAZOTIDE-M/007. 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.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-LARAZOTIDE-M/008. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
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-060/3 · https://compoundevidence.com/comment-periods/draft-larazotide-monograph/disposition/ · retrieved 30 July 2026