Public comment period · §3
Draft monograph: DSIP — 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-DSIP-MONOGRA/001 | Dr Abimbola Sotomayor-Ekwueme | Storage and reconstitution guidance is given without stating what it rests on | Accepted in part |
| DRAFT-DSIP-MONOGRA/002 | Dr Quentin Gwynne-Sarpong | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| DRAFT-DSIP-MONOGRA/003 | Dr Frideswide Nordhagen | The interaction section lists mechanisms rather than interactions | Accepted in part |
| DRAFT-DSIP-MONOGRA/004 | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction | Accepted |
| 4 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 2 | 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 | 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
- Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-DSIP-MONOGRA/001. 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.
- The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-DSIP-MONOGRA/002. 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 interaction section lists mechanisms rather than interactions — arising from DRAFT-DSIP-MONOGRA/003. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-DSIP-MONOGRA/004. 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.
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-045/3 · https://compoundevidence.com/comment-periods/draft-dsip-monograph/disposition/ · retrieved 30 July 2026