Draft monograph: BPC-157 — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-BPC-157-MONO/001. 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.
2. The indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-BPC-157-MONO/002. The indication table now carries a status column with three values, approved, under investigation and supplied without trial evidence, and the value is stated for every row. Rows in the third category also state that no certainty rating is assigned because…
3. The interaction section lists mechanisms rather than interactions — arising from DRAFT-BPC-157-MONO/003. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
4. A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-BPC-157-MONO/004. 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.
5. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-BPC-157-MONO/005. 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.
6. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-BPC-157-MONO/006. 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…
7. Preclinical findings are reported without the model that produced them — arising from DRAFT-BPC-157-MONO/007. Every preclinical statement in the series now carries the model and, where the source reports it, the dose and the route.
8. The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-BPC-157-MONO/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.

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.

1. 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

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