Draft monograph: Survodutide — 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-SURVODUTIDE-/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.
2. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SURVODUTIDE-/002. 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.
3. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-SURVODUTIDE-/003. 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.
4. Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-SURVODUTIDE-/004. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
5. Nothing is said about impaired renal or hepatic clearance — arising from DRAFT-SURVODUTIDE-/005. 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.
6. The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-SURVODUTIDE-/006. 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.
7. Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-SURVODUTIDE-/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.
8. The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-SURVODUTIDE-/009. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.
9. The interaction section lists mechanisms rather than interactions — arising from DRAFT-SURVODUTIDE-/010. The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
10. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-SURVODUTIDE-/011. 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…
11. The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-SURVODUTIDE-/012. The pharmacokinetic section now states approximate time to steady state alongside the half-life and dosing interval, with the assumption of first-order elimination stated, and records where the assumption is not supported for this compound.
12. A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-SURVODUTIDE-/013. 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.
13. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-SURVODUTIDE-/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…

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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