Public comment period · §3
Draft monograph: Selank — 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-SELANK-MONOG/001 | Dr Rurik Haverkamp-Diallo | The document set should be published in translation | Not accepted |
| DRAFT-SELANK-MONOG/002 | Dr Xenia Nyquist-Obiora | The route of administration studied is not the route in which the compound is supplied | Accepted |
| DRAFT-SELANK-MONOG/003 | Dr Ludmila Tollemache | The monograph should state what the compound costs | Not accepted |
| DRAFT-SELANK-MONOG/004 | Dr Frideswide Nordhagen | The interaction section lists mechanisms rather than interactions | Accepted in part |
| DRAFT-SELANK-MONOG/005 | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described | Accepted |
| DRAFT-SELANK-MONOG/006 | Dr Liesbeth Nordhagen industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-SELANK-MONOG/007 | Dr Melisande Thorsby-Nakamura | The monograph does not tell a reader that two vials of the same compound may not contain the same thing | Accepted |
| DRAFT-SELANK-MONOG/008 | Georgiana Zimmerthal | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| 8 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 | 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 | 2 | 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 route of administration studied is not the route in which the compound is supplied — arising from DRAFT-SELANK-MONOG/002. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
- The interaction section lists mechanisms rather than interactions — arising from DRAFT-SELANK-MONOG/004. 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.
- A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-SELANK-MONOG/005. The analytical section now states the resolving power required to discriminate the pair, names the pair explicitly, and records that an identity claim made below that resolution is not conformant with the identity standard.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-SELANK-MONOG/006. The approved indication and contraindications are now reproduced verbatim from the named authorisation with its version and date, and the posology section reports the labelled schedule and the schedules studied side by side, with the source of each stated.
- The monograph does not tell a reader that two vials of the same compound may not contain the same… — arising from DRAFT-SELANK-MONOG/007. 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-073/3 · https://compoundevidence.com/comment-periods/draft-selank-monograph/disposition/ · retrieved 30 July 2026