Public comment period · §3
Draft monograph: GHK-Cu — 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-GHK-CU-MONOG/003 | Dr Yehudit Yorkstone | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-GHK-CU-MONOG/006 | Radoslava Palmgren-Kofi | Regulatory status is stated without naming the jurisdiction | Accepted |
| DRAFT-GHK-CU-MONOG/004 | Dr Melisande Thorsby-Nakamura industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-GHK-CU-MONOG/001 | Dr Jacinta Grünbaum-Sowande | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-GHK-CU-MONOG/002 | Dr Lorcan Uttridge | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-GHK-CU-MONOG/005 | Dr Sigrún Lavrentiev | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-GHK-CU-MONOG/007 | Dr Jacinta Steenkamp-Ferreira | The monograph should state what the compound costs | Not accepted |
| 7 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 | 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 | 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 | 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 pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-GHK-CU-MONOG/003. 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.
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-GHK-CU-MONOG/006. Every regulatory status statement now names the authority, states the date on which the status was verified, and is recorded per jurisdiction rather than as a single global assertion.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-GHK-CU-MONOG/004. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-GHK-CU-MONOG/001. 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.
- What happens when the compound is stopped is not addressed — arising from DRAFT-GHK-CU-MONOG/002. 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.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-GHK-CU-MONOG/005. 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-050/3 · https://compoundevidence.com/comment-periods/draft-ghk-cu-monograph/disposition/ · retrieved 30 July 2026