Draft monograph: Dulaglutide — 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. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-DULAGLUTIDE-/007. 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…
2. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-DULAGLUTIDE-/011. 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. Registered trials that never reported are absent from the monograph — arising from DRAFT-DULAGLUTIDE-/006. The trial list now includes every registered trial the Institute identified, with its reporting status stated, and the monograph reports the proportion of registered trials for which no result has been posted or published.
4. What happens when the compound is stopped is not addressed — arising from DRAFT-DULAGLUTIDE-/005. 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.
5. The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-DULAGLUTIDE-/004. 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.
6. The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-DULAGLUTIDE-/002. 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.
7. The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-DULAGLUTIDE-/003. 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.
8. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-DULAGLUTIDE-/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.
9. Trials are described as terminated where they completed as planned — arising from DRAFT-DULAGLUTIDE-/010. 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.
10. Effect estimates are given without naming the comparator — arising from DRAFT-DULAGLUTIDE-/008. The comparator is now stated in every outcome row, and estimates against different comparators are reported in separate tables with the comparator named in the table caption.
11. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-DULAGLUTIDE-/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.

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.