Draft monograph: Ipamorelin — 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-IPAMORELIN-M/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. Registered trials that never reported are absent from the monograph — arising from DRAFT-IPAMORELIN-M/002. 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.
3. Storage and reconstitution guidance is given without stating what it rests on — arising from DRAFT-IPAMORELIN-M/003. In-use periods now appear only where supported by a cited stability determination on a stated presentation, and elsewhere the monograph records that no in-use stability evidence was identified for this presentation.
4. The interaction section lists mechanisms rather than interactions — arising from DRAFT-IPAMORELIN-M/004. 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.
5. Two factual descriptions of the sponsor's programme are inaccurate — arising from DRAFT-IPAMORELIN-M/006. 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…
6. The search date is not on the face of the document — arising from DRAFT-IPAMORELIN-M/007. The search date is now printed adjacent to every certainty rating and is carried in the document metadata, so that the interval between the search and the reading is visible without reference to the methods section.
7. The preclinical section is extensive and the clinical section is not — arising from DRAFT-IPAMORELIN-M/008. 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.
8. The indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-IPAMORELIN-M/009. The indication table now carries a status column with three values, approved, under investigation and supplied without trial evidence, and the value is stated for every row. Rows in the third category also state that no certainty rating is assigned because…
9. A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-IPAMORELIN-M/010. Purity and content are now reported in separate rows with separate definitions, and the monograph states that a purity figure sets no bound on content and that a content figure requires a determination against a standard of assigned content.

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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