Public comment period · §3
Draft monograph: Thymosin alpha-1 — 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-THYMOSIN-ALP/007 | Dr Melisande Thorsby-Nakamura | A sortable table implies a comparison the underlying data do not support | Noted, no amendment |
| DRAFT-THYMOSIN-ALP/013 | Dr Abimbola Sotomayor-Ekwueme | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials | Accepted |
| DRAFT-THYMOSIN-ALP/006 | Dr Sigrún Lavrentiev | Trials are described as terminated where they completed as planned | Accepted in part |
| DRAFT-THYMOSIN-ALP/004 | Dr Jacinta Steenkamp-Ferreira | References should carry a persistent identifier for every cited source | Accepted in part |
| DRAFT-THYMOSIN-ALP/011 | Ivo Mountstephen | The document set should be published in translation | Not accepted |
| DRAFT-THYMOSIN-ALP/005 | Radoslava Palmgren-Kofi | Evidence for one member of the class is presented as evidence for this compound | Accepted |
| DRAFT-THYMOSIN-ALP/009 | Dr Dmitri Nordhagen | Adverse event frequencies are given without the denominator or the exposure period | Accepted |
| DRAFT-THYMOSIN-ALP/002 | Dr Lorcan Zaleski-Mbeki | The search date is not on the face of the document | Accepted |
| DRAFT-THYMOSIN-ALP/003 | Dr Mordecai Bellingham-Ojo | The analytical section assumes a reference standard that is not generally available | Accepted |
| DRAFT-THYMOSIN-ALP/012 | Dr Wilhelmina Quaresma | The document should state what a reader ought to do | Not accepted |
| DRAFT-THYMOSIN-ALP/008 | Dr Yehudit Yorkstone | Doses are expressed in units that differ between sections | Accepted |
| DRAFT-THYMOSIN-ALP/010 | Dr Liesbeth Quenneville | A near-isobaric analogue is not distinguished by the identity determination described | Accepted |
| DRAFT-THYMOSIN-ALP/001 | Dr Katarzyna Yorkstone | Registered trials that never reported are absent from the monograph | Accepted |
| 13 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 8 | 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 certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-THYMOSIN-ALP/013. 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.
- Trials are described as terminated where they completed as planned — arising from DRAFT-THYMOSIN-ALP/006. Trial status now uses a fixed vocabulary defined in the glossary, and where the reason for stopping is not evidenced by a document the Institute holds, the status is recorded as stopped with the reason not established rather than assigned.
- References should carry a persistent identifier for every cited source — arising from DRAFT-THYMOSIN-ALP/004. Every reference without a persistent identifier now carries an explicit statement that the identifier is not held by the Institute, so that its absence is a recorded fact rather than an apparent oversight.
- Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-THYMOSIN-ALP/005. 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.
- Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-THYMOSIN-ALP/009. 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.
- The search date is not on the face of the document — arising from DRAFT-THYMOSIN-ALP/002. 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 analytical section assumes a reference standard that is not generally available — arising from DRAFT-THYMOSIN-ALP/003. The analytical section now states whether a reference standard is in general circulation for this compound and, where it is not, states which determinations remain possible and which become qualitative. A content figure obtained without a reference standard…
- Doses are expressed in units that differ between sections — arising from DRAFT-THYMOSIN-ALP/008. 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.
- A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-THYMOSIN-ALP/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.
- Registered trials that never reported are absent from the monograph — arising from DRAFT-THYMOSIN-ALP/001. 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.
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-082/3 · https://compoundevidence.com/comment-periods/draft-thymosin-alpha-1-monograph/disposition/ · retrieved 30 July 2026