Public comment period · §3
Draft monograph: NAD+ (nicotinamide adenine dinucleotide) — 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-NAD-PLUS-MON/001 | Dr Xenia Nyquist-Obiora | Guidance on lyophilised storage is missing | Noted, no amendment |
| DRAFT-NAD-PLUS-MON/002 | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described | Accepted |
| DRAFT-NAD-PLUS-MON/003 | Dr Ndidi Ravensworth-Ilunga | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| DRAFT-NAD-PLUS-MON/004 | Dr Liesbeth Nordhagen industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-NAD-PLUS-MON/005 | Dr Hortensia Larsson-Ekwueme | Local reactions are omitted from the adverse-event table because the trials reported them separately | Accepted |
| DRAFT-NAD-PLUS-MON/006 | Dr Emiliana Ollerenshaw | The document set should be published in translation | Not accepted |
| DRAFT-NAD-PLUS-MON/007 | Dr Delphine Trelawney | The mechanism section is written with more confidence than the clinical section it precedes | Accepted in part |
| DRAFT-NAD-PLUS-MON/008 | Dr Lorcan Trelawney | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-NAD-PLUS-MON/009 | Dr Fitzwilliam Danquah-Öberg | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water | Accepted |
| 9 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 5 | 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 | 1 | 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
- A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-NAD-PLUS-MON/002. 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 certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-NAD-PLUS-MON/003. 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.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-NAD-PLUS-MON/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.
- Local reactions are omitted from the adverse-event table because the trials reported them separately — arising from DRAFT-NAD-PLUS-MON/005. Local reactions are now carried in the adverse-event table wherever the source trials report them, footnoted with the convention each trial used.
- The mechanism section is written with more confidence than the clinical section it precedes — arising from DRAFT-NAD-PLUS-MON/007. Every pharmacology section now closes with a statement identifying which described actions are supported by clinical evidence assessed in §3 and which are not. The pharmacology itself is stated as the sources state it.
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-NAD-PLUS-MON/008. 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.
- The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-NAD-PLUS-MON/009. 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.
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-068/3 · https://compoundevidence.com/comment-periods/draft-nad-plus-monograph/disposition/ · retrieved 30 July 2026