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. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-AOD-9604-MON/001. 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…
2. Nothing is said about impaired renal or hepatic clearance — arising from DRAFT-AOD-9604-MON/002. The pharmacokinetic table now carries renal and hepatic rows in every monograph, populated with the study where one exists and with an explicit statement of absence where none does.
3. The search date is not on the face of the document — arising from DRAFT-AOD-9604-MON/003. 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.
4. Trials are described as terminated where they completed as planned — arising from DRAFT-AOD-9604-MON/004. 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.
5. A rise in insulin-like growth factor 1 is reported in the position of a clinical outcome — arising from DRAFT-AOD-9604-MON/005. Biomarker responses now appear in §2 and are excluded from the assessed-outcome table unless the surrogate relationship has been validated, in which case the validation evidence is cited beside it.
6. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-AOD-9604-MON/007. 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.
7. The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-AOD-9604-MON/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.
8. The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-AOD-9604-MON/009. The analytical section is reduced to compound-specific content and cross-references the relevant standards for the general procedure, which shortens it substantially without removing what is not available elsewhere.
9. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-AOD-9604-MON/010. 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 absence of paediatric evidence is not stated where a reader would look for it — arising from DRAFT-AOD-9604-MON/012. The population table now carries a paediatric row in every monograph, and where evidence exists the trials are named.
11. Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-AOD-9604-MON/013. 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.
12. Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-AOD-9604-MON/014. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
13. What happens when the compound is stopped is not addressed — arising from DRAFT-AOD-9604-MON/015. 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.
14. The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-AOD-9604-MON/016. Each assessed outcome now carries its downgrade domains in the summary-of-findings row, with a short statement of the judgement made in each, so that the rating can be checked domain by domain against the contributing trials.

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

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.