Draft monograph: Mazdutide — 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. Trials are described as terminated where they completed as planned — arising from DRAFT-MAZDUTIDE-MO/001. 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.
2. Point estimates are given without an interval — arising from DRAFT-MAZDUTIDE-MO/002. 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.
3. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-MAZDUTIDE-MO/003. 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.
4. Anti-drug antibody data are omitted — arising from DRAFT-MAZDUTIDE-MO/004. 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.
5. The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-MAZDUTIDE-MO/006. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
6. Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-MAZDUTIDE-MO/007. 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.
7. The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-MAZDUTIDE-MO/008. 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.
8. The indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-MAZDUTIDE-MO/009. 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…

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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