Public comment period · §3
Draft monograph: BPC-157 — 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-BPC-157-MONO/007 | Dr Hortensia Larsson-Ekwueme industry | The document should not describe uses outside the approved indication | Not accepted |
| DRAFT-BPC-157-MONO/003 | Dr Oswin Yorkstone | The pharmacokinetic section does not connect half-life to the dosing schedule | Accepted |
| DRAFT-BPC-157-MONO/004 | Dr Kamila Ubertini | Absence of evidence is presented in a form a reader will take as negative evidence | Accepted |
| DRAFT-BPC-157-MONO/006 | Dr Theodora Ingelbrecht | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water | Accepted |
| DRAFT-BPC-157-MONO/001 | Dr Delphine Trelawney | The absence of a rare harm in the trial set is presented as reassurance | Accepted |
| DRAFT-BPC-157-MONO/002 | Dr Quentin Whitmarsh-Obi | What happens when the compound is stopped is not addressed | Accepted |
| DRAFT-BPC-157-MONO/005 | Dr Quintus Kettlewell | Every contributing trial shares one sponsor and the monograph does not say so | Accepted |
| DRAFT-BPC-157-MONO/008 | Dr Ottoline Oppenheimer-Ade | The population to which the headline estimate applies is not stated with the estimate | Accepted |
| 8 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 7 | 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 | 0 | 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 | 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
- The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-BPC-157-MONO/003. 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.
- Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-BPC-157-MONO/004. A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at…
- The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-BPC-157-MONO/006. 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.
- The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-BPC-157-MONO/001. 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.
- What happens when the compound is stopped is not addressed — arising from DRAFT-BPC-157-MONO/002. 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.
- Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-BPC-157-MONO/005. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
- The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-BPC-157-MONO/008. Every headline estimate now carries a one-line statement of the population in which it was observed, and the full eligibility criteria are reported in the included-studies table rather than only in the source.
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-007/3 · https://compoundevidence.com/comment-periods/draft-bpc-157-monograph/disposition/ · retrieved 30 July 2026