Draft monograph: IGF-1 LR3 — 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-IGF-1-LR3-MO/006. 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. The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-IGF-1-LR3-MO/005. 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.
3. The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-IGF-1-LR3-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.
4. Doses are expressed in units that differ between sections — arising from DRAFT-IGF-1-LR3-MO/007. A single dose unit is now used throughout each monograph, with the source unit retained in parentheses wherever a conversion was applied, and every conversion is stated rather than performed silently.
5. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-IGF-1-LR3-MO/002. Every quantitative claim now carries the determination that produced it at the point of use, and figures obtained by non-comparable methods are no longer presented in the same row or sentence.
6. Anti-drug antibody data are omitted — arising from DRAFT-IGF-1-LR3-MO/003. 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.
7. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-IGF-1-LR3-MO/009. 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.
8. The preclinical section is extensive and the clinical section is not — arising from DRAFT-IGF-1-LR3-MO/004. The preclinical section is reduced in length, placed after the clinical assessment rather than before it, and opens with a standing statement that an effect observed in an animal model is not a clinical outcome and does not support a certainty rating.

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.