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-/001 | Dr Matthias Whitmarsh-Obi | Nothing is said about impaired renal or hepatic clearance | Accepted |
| DRAFT-TEDUGLUTIDE-/002 | Dr Zdenka Nyquist-Obiora | Evidence for one member of the class is presented as evidence for this compound | Accepted |
| DRAFT-TEDUGLUTIDE-/003 | Ivo Mountstephen | The search date is not on the face of the document | Accepted |
| DRAFT-TEDUGLUTIDE-/004 | Bertrand Ollerenshaw industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-TEDUGLUTIDE-/005 | Dr Liesbeth Zaleski-Mbeki | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-TEDUGLUTIDE-/006 | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-TEDUGLUTIDE-/007 | Dr Hyacinth Drakeford-Amadi | Doses are expressed in units that differ between sections | Accepted |
| 7 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 6 | 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 | 1 | 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
- Nothing is said about impaired renal or hepatic clearance — arising from DRAFT-TEDUGLUTIDE-/001. The pharmacokinetic table now carries renal and hepatic rows in every monograph, populated with the study where one exists and with an explicit statement of absence where none does.
- Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-TEDUGLUTIDE-/002. Class-level inferences are now labelled at the point of use, are excluded from the certainty rating for the compound, and are reported in a separate subsection stating which compound the underlying evidence concerns.
- The search date is not on the face of the document — arising from DRAFT-TEDUGLUTIDE-/003. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-TEDUGLUTIDE-/004. 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 pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-TEDUGLUTIDE-/005. 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.
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-TEDUGLUTIDE-/006. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
- Doses are expressed in units that differ between sections — arising from DRAFT-TEDUGLUTIDE-/007. A single dose unit is now used throughout each monograph, with the source unit retained in parentheses wherever a conversion was applied, and every conversion is stated rather than performed silently.
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