Public comment period · §3
Draft monograph: Teduglutide — 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-TEDUGLUTIDE-/003 | Dr Katarzyna Oppenheimer-Ade industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-TEDUGLUTIDE-/002 | Dr Vittoria Ylönen | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-TEDUGLUTIDE-/005 | Dr Anselm Ashworth-Danquah | Point estimates are given without an interval | Accepted in part |
| DRAFT-TEDUGLUTIDE-/004 | Dr Ivo Quintanilha | Storage and reconstitution guidance is given without stating what it rests on | Accepted in part |
| DRAFT-TEDUGLUTIDE-/001 | Dr Mordecai Glendinning-Uche | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water | Accepted |
| DRAFT-TEDUGLUTIDE-/006 | Dr Bertrand Steenkamp-Ferreira | The analytical section is longer than the clinical assessment it accompanies | Accepted in part |
| DRAFT-TEDUGLUTIDE-/007 | Dr Vasilisa Immelmann | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| 7 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 | 4 | 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
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-TEDUGLUTIDE-/003. 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.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-TEDUGLUTIDE-/002. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- Point estimates are given without an interval — arising from DRAFT-TEDUGLUTIDE-/005. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
- Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-TEDUGLUTIDE-/004. 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 monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-TEDUGLUTIDE-/001. The monograph now states, at the point where vial contents are first mentioned, that a mass figure is uninterpretable unless it states whether it is peptide content or total solids, and cross-references the content standard in the analytical series.
- The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-TEDUGLUTIDE-/006. 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 certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-TEDUGLUTIDE-/007. Each assessed outcome now carries its downgrade domains in the summary-of-findings row, with a short statement of the judgement made in each, so that the rating can be checked domain by domain against the contributing trials.
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-079/3 · https://compoundevidence.com/comment-periods/draft-teduglutide-monograph/disposition/ · retrieved 30 July 2026