Draft monograph: amycretin — 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. Point estimates are given without an interval — arising from DRAFT-AMYCRETIN-MO/005. 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.
2. The preclinical section is extensive and the clinical section is not — arising from DRAFT-AMYCRETIN-MO/013. 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.
3. The compound is supplied under names the monograph does not list — arising from DRAFT-AMYCRETIN-MO/008. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
4. The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-AMYCRETIN-MO/014. 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.
5. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-AMYCRETIN-MO/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.
6. The search date is not on the face of the document — arising from DRAFT-AMYCRETIN-MO/011. 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. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-AMYCRETIN-MO/002. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
8. Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-AMYCRETIN-MO/015. Class-level inferences are now labelled at the point of use, are excluded from the certainty rating for the compound, and are reported in a separate subsection stating which compound the underlying evidence concerns.
9. Doses are expressed in units that differ between sections — arising from DRAFT-AMYCRETIN-MO/003. 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.
10. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-AMYCRETIN-MO/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.
11. The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-AMYCRETIN-MO/004. 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.
12. Anti-drug antibody data are omitted — arising from DRAFT-AMYCRETIN-MO/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.

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.