Public comment period · §3
Draft synthesis: Dependence of reported purity on the… — 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-PEPTIDE-PURI/001 | Eamon Sandringham-Adu | The review protocol is described but its registration record is not linked | Accepted in part |
| DRAFT-PEPTIDE-PURI/002 | Dr Anselm Thorsby-Nakamura | Results obtained by different methods are pooled without recording the method | Accepted |
| DRAFT-PEPTIDE-PURI/003 | Thaddeus Isaksen-Balogun | Multiple vials from one lot are counted as independent observations | Accepted in part |
| DRAFT-PEPTIDE-PURI/004 | Professor Bartolomeu Nkosi-Lindegaard | Regulatory assessment documents were not searched | Accepted in part |
| 4 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 1 | 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 | 3 | 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 review protocol is described but its registration record is not linked — arising from DRAFT-PEPTIDE-PURI/001. Each synthesis now links its own protocol with the version in force at screening, and states explicitly where an external registration identifier is not held, so that the absence is a recorded fact.
- Results obtained by different methods are pooled without recording the method — arising from DRAFT-PEPTIDE-PURI/002. Every contributing result now carries its determination, pooling occurs only within a determination, and where a survey did not report the method the result is listed as method not stated and excluded from the pooled estimates.
- Multiple vials from one lot are counted as independent observations — arising from DRAFT-PEPTIDE-PURI/003. The unit of analysis is now the lot throughout, the number of lots is reported beside the number of vials, and within-lot variation is reported as a separate quantity rather than folded into the pooled interval.
- Regulatory assessment documents were not searched — arising from DRAFT-PEPTIDE-PURI/004. Published regulatory assessment documents are now searched as a named source, are reported as a distinct evidence class in the included-studies table, and contribute to the assessment while being excluded from pooled estimates where risk of bias could not be…
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-119/3 · https://compoundevidence.com/comment-periods/draft-peptide-purity-method-dependence-synthesis/disposition/ · retrieved 30 July 2026