Public comment period · §3
Draft monograph: Sermorelin — 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-SERMORELIN-M/004 | Dr Oswin Yorkstone | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-SERMORELIN-M/006 | Dr Ludmila Castellanos-Reid | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-SERMORELIN-M/005 | Dr Vasilisa Immelmann | The same concept is given three different names in one document | Accepted |
| DRAFT-SERMORELIN-M/008 | Dr Bertrand Steenkamp-Ferreira | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-SERMORELIN-M/003 | Dr Kamila Ubertini | The recorded evidence gaps omit outcomes a reader would consider material | Accepted in part |
| DRAFT-SERMORELIN-M/007 | Dr Anselm Ashworth-Danquah | A superseded version should remain reachable from the version that replaced it | Noted, no amendment |
| DRAFT-SERMORELIN-M/002 | Dr Delphine Trelawney | Storage and reconstitution guidance is given without stating what it rests on | Accepted in part |
| DRAFT-SERMORELIN-M/001 | Dr Quentin Whitmarsh-Obi | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-SERMORELIN-M/009 | Dr Rosalind Grünbaum-Sowande | Doses are expressed in units that differ between sections | Accepted |
| 9 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 | 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
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-SERMORELIN-M/004. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- The compound is supplied under names the monograph does not list — arising from DRAFT-SERMORELIN-M/006. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
- The same concept is given three different names in one document — arising from DRAFT-SERMORELIN-M/005. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-SERMORELIN-M/008. 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 recorded evidence gaps omit outcomes a reader would consider material — arising from DRAFT-SERMORELIN-M/003. 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.
- Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-SERMORELIN-M/002. In-use periods now appear only where supported by a cited stability determination on a stated presentation, and elsewhere the monograph records that no in-use stability evidence was identified for this presentation.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-SERMORELIN-M/001. 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.
- Doses are expressed in units that differ between sections — arising from DRAFT-SERMORELIN-M/009. A single dose unit is now used throughout each monograph, with the source unit retained in parentheses wherever a conversion was applied, and every conversion is stated rather than performed silently.
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-075/3 · https://compoundevidence.com/comment-periods/draft-sermorelin-monograph/disposition/ · retrieved 30 July 2026