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 | Radoslava Palmgren-Kofi | Regulatory status is stated without naming the jurisdiction | Accepted |
| DRAFT-DSIP-MONOGRA/003 | Dr Melisande Thorsby-Nakamura industry | Two factual descriptions of the sponsor's programme are inaccurate | Accepted |
| DRAFT-DSIP-MONOGRA/002 | Dr Sigrún Lavrentiev | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-DSIP-MONOGRA/004 | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| 4 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 | 0 | 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
- Regulatory status is stated without naming the jurisdiction — arising from DRAFT-DSIP-MONOGRA/001. 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.
- Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-DSIP-MONOGRA/003. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-DSIP-MONOGRA/002. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-DSIP-MONOGRA/004. Mechanistic claims not traceable to a primary source are removed, and those retained carry their source and a statement of whether the underlying work was conducted in vitro, in animals or in humans.
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