Public comment period · §3
Draft monograph: 5-amino-1MQ — 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-5-AMINO-1MQ-/005 | Dr Katarzyna Yorkstone | The compound is supplied under names the monograph does not list | Accepted |
| DRAFT-5-AMINO-1MQ-/006 | Dr Lorcan Zaleski-Mbeki industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-5-AMINO-1MQ-/001 | Quentin Gwynne-Sarpong | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| DRAFT-5-AMINO-1MQ-/002 | Dr Wolfram Kaltenbach-Mensah | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-5-AMINO-1MQ-/004 | Dr Zebedee Zaleski-Mbeki | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-5-AMINO-1MQ-/003 | Dr Ottoline Fitzgerald-Nwosu | The recorded evidence gaps omit outcomes a reader would consider material | Accepted in part |
| 6 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 3 | 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 | 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 compound is supplied under names the monograph does not list — arising from DRAFT-5-AMINO-1MQ-/005. 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 population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-5-AMINO-1MQ-/001. 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.
- The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-5-AMINO-1MQ-/002. 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.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-5-AMINO-1MQ-/004. 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-5-AMINO-1MQ-/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.
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-040/3 · https://compoundevidence.com/comment-periods/draft-5-amino-1mq-monograph/disposition/ · retrieved 30 July 2026