Draft monograph: GHRP-6 — 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 same concept is given three different names in one document — arising from DRAFT-GHRP-6-MONOG/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.
2. Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-GHRP-6-MONOG/007. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.
3. Anti-drug antibody data are omitted — arising from DRAFT-GHRP-6-MONOG/001. 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.
4. A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-GHRP-6-MONOG/006. 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.
5. Trials are described as terminated where they completed as planned — arising from DRAFT-GHRP-6-MONOG/004. 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.
6. The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-GHRP-6-MONOG/009. 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.
7. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-GHRP-6-MONOG/008. 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-GHRP-6-MONOG/010. 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.
9. The indication table mixes approved indications with uses for which the compound is merely supplied — arising from DRAFT-GHRP-6-MONOG/005. 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…

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.