Draft monograph: Semax — 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. Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-SEMAX-MONOGR/005. 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.
2. Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-SEMAX-MONOGR/014. In-use periods now appear only where supported by a cited stability determination on a stated presentation, and elsewhere the monograph records that no in-use stability evidence was identified for this presentation.
3. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-SEMAX-MONOGR/007. The trial status now reads as completed at a pre-specified interim analysis, with the analysis identified, and the dose is stated in the unit used in the approved labelling. The submission is identified as an industry submission on its face in accordance with…
4. Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… — arising from DRAFT-SEMAX-MONOGR/011. Cardiovascular outcomes are now an assessed outcome with their own certainty rating in every monograph for which a dedicated cardiovascular outcome trial of that compound has reported, and are recorded as not assessed elsewhere.
5. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SEMAX-MONOGR/013. 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.
6. Effect estimates are given without naming the comparator — arising from DRAFT-SEMAX-MONOGR/004. The comparator is now stated in every outcome row, and estimates against different comparators are reported in separate tables with the comparator named in the table caption.
7. What happens when the compound is stopped is not addressed — arising from DRAFT-SEMAX-MONOGR/001. 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.
8. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-SEMAX-MONOGR/003. 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…
9. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-SEMAX-MONOGR/015. 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.
10. The document is unreadable without specialist training — arising from DRAFT-SEMAX-MONOGR/012. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
11. A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-SEMAX-MONOGR/002. 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.
12. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-SEMAX-MONOGR/009. Every regulatory status statement now names the authority, states the date on which the status was verified, and is recorded per jurisdiction rather than as a single global assertion.
13. Trials are described as terminated where they completed as planned — arising from DRAFT-SEMAX-MONOGR/010. 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 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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