Public comment period · §3
Draft monograph: IGF-1 LR3 — 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-IGF-1-LR3-MO/001 | Dr Ngozi Zetterlund | The absence of paediatric evidence is not stated where a reader would look for it | Accepted |
| DRAFT-IGF-1-LR3-MO/002 | Dr Marisol Dunmore-Ekpo | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-IGF-1-LR3-MO/003 | Dr Lorcan Trelawney | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-IGF-1-LR3-MO/004 | Dr Emiliana Ollerenshaw | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-IGF-1-LR3-MO/005 | Dr Constança Glendinning-Uche | The same concept is given three different names in one document | Accepted |
| DRAFT-IGF-1-LR3-MO/006 | Dr Zdenka Nyquist-Obiora | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-IGF-1-LR3-MO/007 | Dr Evander Whitmarsh-Obi | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-IGF-1-LR3-MO/008 | Dr Liesbeth Zaleski-Mbeki | The mechanism section is written with more confidence than the clinical section it precedes | Accepted in part |
| DRAFT-IGF-1-LR3-MO/009 | Dr Quentin Zimmerthal | The monograph does not tell a reader that two vials of the same compound may not contain the same thing | Accepted |
| 9 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 | 2 | 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 absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-IGF-1-LR3-MO/001. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-IGF-1-LR3-MO/002. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-IGF-1-LR3-MO/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 same concept is given three different names in one document — arising from DRAFT-IGF-1-LR3-MO/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-IGF-1-LR3-MO/006. 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.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-IGF-1-LR3-MO/007. 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 mechanism section is written with more confidence than the clinical section it precedes — arising from DRAFT-IGF-1-LR3-MO/008. Every pharmacology section now closes with a statement identifying which described actions are supported by clinical evidence assessed in §3 and which are not. The pharmacology itself is stated as the sources state it.
- The monograph does not tell a reader that two vials of the same compound may not contain the same… — arising from DRAFT-IGF-1-LR3-MO/009. 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.
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-056/3 · https://compoundevidence.com/comment-periods/draft-igf-1-lr3-monograph/disposition/ · retrieved 30 July 2026