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. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-SURVODUTIDE-/001. 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.
2. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-SURVODUTIDE-/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.
3. A near-isobaric analogue is not distinguished by the identity determination described — arising from DRAFT-SURVODUTIDE-/002. 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.
4. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SURVODUTIDE-/010. 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.
5. The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-SURVODUTIDE-/007. 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.
6. The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-SURVODUTIDE-/008. 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.
7. Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-SURVODUTIDE-/011. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
8. Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-SURVODUTIDE-/012. Every reported frequency now carries the number of participants, the number of events and the exposure period, and comparator-arm figures are reported alongside rather than in a separate table.
9. The analytical section assumes a reference standard that is not generally available — arising from DRAFT-SURVODUTIDE-/013. The analytical section now states whether a reference standard is in general circulation for this compound and, where it is not, states which determinations remain possible and which become qualitative. A content figure obtained without a reference standard…
10. Trials are described as terminated where they completed as planned — arising from DRAFT-SURVODUTIDE-/005. 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.
11. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-SURVODUTIDE-/003. 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…

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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