Public comment period · §3
Draft monograph: Glutathione — 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-GLUTATHIONE-/001 | Dr Ludmila Tollemache | The monograph should state what the compound costs | Not accepted |
| DRAFT-GLUTATHIONE-/002 | Dr Adaeze Underhill-Okafor | Open-label extension data are presented alongside randomised data without distinction | Accepted |
| DRAFT-GLUTATHIONE-/003 | Dr Vasilisa Sandringham-Adu | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-GLUTATHIONE-/004 | Dr Hyacinth Oyelaran-Steen | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-GLUTATHIONE-/005 | Dr Odalys Thorsby-Nakamura | Registered trials that never reported are absent from the monograph | Accepted |
| DRAFT-GLUTATHIONE-/006 | Georgiana Zimmerthal | The document set should be published in translation | Not accepted |
| DRAFT-GLUTATHIONE-/007 | Dr Liesbeth Nordhagen industry | The monograph should reproduce the approved labelling rather than paraphrase it | Accepted in part |
| DRAFT-GLUTATHIONE-/008 | Dr Ivo Quintanilha | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-GLUTATHIONE-/009 | Dr Ottoline Fitzgerald-Nwosu | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as described | Accepted |
| DRAFT-GLUTATHIONE-/010 | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described | Accepted |
| DRAFT-GLUTATHIONE-/011 | Dr Marisol Dunmore-Ekpo | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| DRAFT-GLUTATHIONE-/012 | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure | Accepted |
| DRAFT-GLUTATHIONE-/013 | Dr Rurik Haverkamp-Diallo | Declared interests should appear on the document rather than on a separate page | Noted, no amendment |
| DRAFT-GLUTATHIONE-/014 | Dr Kamila Glendinning-Uche | Preclinical findings are reported without the model that produced them | Accepted |
| 14 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 9 | 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 | 2 | 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
- Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-GLUTATHIONE-/002. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
- What happens when the compound is stopped is not addressed — arising from DRAFT-GLUTATHIONE-/004. Discontinuation trajectory is now an assessed outcome in every monograph where a contributing trial measured it, and a recorded evidence gap in every monograph where none did, so that its absence is visible rather than silent.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-GLUTATHIONE-/005. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
- The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-GLUTATHIONE-/007. 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-GLUTATHIONE-/008. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-GLUTATHIONE-/009. 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.
- A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-GLUTATHIONE-/010. 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-GLUTATHIONE-/011. 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.
- A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-GLUTATHIONE-/012. Purity and content are now reported in separate rows with separate definitions, and the monograph states that a purity figure sets no bound on content and that a content figure requires a determination against a standard of assigned content.
- Preclinical findings are reported without the model that produced them — arising from DRAFT-GLUTATHIONE-/014. Every preclinical statement in the series now carries the model and, where the source reports it, the dose and the route.
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-053/3 · https://compoundevidence.com/comment-periods/draft-glutathione-monograph/disposition/ · retrieved 30 July 2026