Public comment period · §3
Draft monograph: LL-37 — 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-LL-37-MONOGR/005 | Dr Hamish Nyquist-Obiora | Quantitative claims are reproduced without the method that produced them | Accepted |
| DRAFT-LL-37-MONOGR/006 | Dr Marisol Dunmore-Ekpo | Guidance on lyophilised storage is missing | Noted, no amendment |
| DRAFT-LL-37-MONOGR/001 | Dr Matthias Whitmarsh-Obi | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-LL-37-MONOGR/002 | Dr Wilhelmina Wintringham | Evidence for one member of the class is presented as evidence for this compound | Accepted |
| DRAFT-LL-37-MONOGR/003 | Dr Fenella Lavrentiev | The same concept is given three different names in one document | Accepted |
| DRAFT-LL-37-MONOGR/004 | Ludmila Brackenridge | The analytical section assumes a reference standard that is not generally available | Accepted |
| 6 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 4 | 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
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-LL-37-MONOGR/005. 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.
- Trials are described as terminated where they completed as planned — arising from DRAFT-LL-37-MONOGR/001. Trial status now uses a fixed vocabulary defined in the glossary, and where the reason for stopping is not evidenced by a document the Institute holds, the status is recorded as stopped with the reason not established rather than assigned.
- Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-LL-37-MONOGR/002. Class-level inferences are now labelled at the point of use, are excluded from the certainty rating for the compound, and are reported in a separate subsection stating which compound the underlying evidence concerns.
- The same concept is given three different names in one document — arising from DRAFT-LL-37-MONOGR/003. 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 assumes a reference standard that is not generally available — arising from DRAFT-LL-37-MONOGR/004. The analytical section now states whether a reference standard is in general circulation for this compound and, where it is not, states which determinations remain possible and which become qualitative. A content figure obtained without a reference standard…
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-063/3 · https://compoundevidence.com/comment-periods/draft-ll-37-monograph/disposition/ · retrieved 30 July 2026