Draft monograph: AOD-9604 — 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. What happens when the compound is stopped is not addressed — arising from DRAFT-AOD-9604-MON/009. 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.
2. A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-AOD-9604-MON/011. 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.
3. Doses are expressed in units that differ between sections — arising from DRAFT-AOD-9604-MON/012. 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.
4. Point estimates are given without an interval — arising from DRAFT-AOD-9604-MON/001. Every estimate now carries its interval where the source reported one, and where it did not, the estimate is annotated as reported without an interval rather than left to appear as a precise figure.
5. The preclinical section is extensive and the clinical section is not — arising from DRAFT-AOD-9604-MON/008. The preclinical section is reduced in length, placed after the clinical assessment rather than before it, and opens with a standing statement that an effect observed in an animal model is not a clinical outcome and does not support a certainty rating.
6. The search date is not on the face of the document — arising from DRAFT-AOD-9604-MON/006. 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.
7. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-AOD-9604-MON/014. 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…
8. Anti-drug antibody data are omitted — arising from DRAFT-AOD-9604-MON/007. Anti-drug antibody incidence and any reported association with loss of effect are now reported where measured, and recorded as not measured where the contributing trials did not assess them.
9. Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-AOD-9604-MON/004. 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.
10. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-AOD-9604-MON/016. 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.
11. The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-AOD-9604-MON/003. The approved indication and contraindications are now reproduced verbatim from the named authorisation with its version and date, and the posology section reports the labelled schedule and the schedules studied side by side, with the source of each stated.
12. Effect estimates are given without naming the comparator — arising from DRAFT-AOD-9604-MON/010. 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.

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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