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. The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-DULAGLUTIDE-/001. 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.
2. The same concept is given three different names in one document — arising from DRAFT-DULAGLUTIDE-/002. A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
3. Local reactions are omitted from the adverse-event table because the trials reported them separately — arising from DRAFT-DULAGLUTIDE-/003. Local reactions are now carried in the adverse-event table wherever the source trials report them, footnoted with the convention each trial used.
4. Effect estimates are given without naming the comparator — arising from DRAFT-DULAGLUTIDE-/004. 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.
5. The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-DULAGLUTIDE-/005. 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.
6. Adverse event frequencies are given without the denominator or the exposure period — arising from DRAFT-DULAGLUTIDE-/006. 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.
7. Nothing is said about impaired renal or hepatic clearance — arising from DRAFT-DULAGLUTIDE-/007. 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.
8. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-DULAGLUTIDE-/008. 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.
9. Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-DULAGLUTIDE-/009. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
10. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-DULAGLUTIDE-/010. 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-DULAGLUTIDE-/011. 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.

References cited on this page

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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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