Public comment period · §3
Draft monograph: Ipamorelin — 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-IPAMORELIN-M/007 | Dr Wilhelmina Quaresma | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| DRAFT-IPAMORELIN-M/008 | Ivo Mountstephen | Effect estimates are given without naming the comparator | Accepted |
| DRAFT-IPAMORELIN-M/009 | Dr Jerome Lavrentiev | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-IPAMORELIN-M/010 | Professor Chukwuemeka Rasmussen-Adeyemi | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-IPAMORELIN-M/002 | Dr Theodora Trelawney | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-IPAMORELIN-M/001 | Dr Eamon Sandringham-Adu | Point estimates are given without an interval | Accepted in part |
| DRAFT-IPAMORELIN-M/004 | Brigitta Grünbaum-Sowande | The preclinical section is extensive and the clinical section is not | Accepted in part |
| DRAFT-IPAMORELIN-M/003 | Dr Quentin Zimmerthal | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-IPAMORELIN-M/005 | Dr Ulysses Bellingham-Ojo | The recorded evidence gaps omit outcomes a reader would consider material | Accepted in part |
| DRAFT-IPAMORELIN-M/006 | Dr Abimbola Sotomayor-Ekwueme | The document set should be published in translation | Not accepted |
| 10 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | 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 | 1 | 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 population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-IPAMORELIN-M/007. 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.
- Effect estimates are given without naming the comparator — arising from DRAFT-IPAMORELIN-M/008. The comparator is now stated in every outcome row, and estimates against different comparators are reported in separate tables with the comparator named in the table caption.
- What happens when the compound is stopped is not addressed — arising from DRAFT-IPAMORELIN-M/009. 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.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-IPAMORELIN-M/002. 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.
- Point estimates are given without an interval — arising from DRAFT-IPAMORELIN-M/001. 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-IPAMORELIN-M/004. 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.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-IPAMORELIN-M/003. 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 recorded evidence gaps omit outcomes a reader would consider material — arising from DRAFT-IPAMORELIN-M/005. The evidence-gap section is now derived from the anchor and decision-relevant outcomes for the indication, and any such outcome measured by no contributing trial is recorded as not measured rather than omitted.
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-057/3 · https://compoundevidence.com/comment-periods/draft-ipamorelin-monograph/disposition/ · retrieved 30 July 2026