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. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-GHRP-6-MONOG/002. 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.
2. The document is unreadable without specialist training — arising from DRAFT-GHRP-6-MONOG/003. Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
3. The analytical section assumes a reference standard that is not generally available — arising from DRAFT-GHRP-6-MONOG/005. The analytical section now states whether a reference standard is in general circulation for this compound and, where it is not, states which determinations remain possible and which become qualitative. A content figure obtained without a reference standard…
4. Registered trials that never reported are absent from the monograph — arising from DRAFT-GHRP-6-MONOG/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.
5. The same concept is given three different names in one document — arising from DRAFT-GHRP-6-MONOG/007. 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.
6. The recorded evidence gaps omit outcomes a reader would consider material — arising from DRAFT-GHRP-6-MONOG/008. The evidence-gap section is now derived from the anchor and decision-relevant outcomes for the indication, and any such outcome measured by no contributing trial is recorded as not measured rather than omitted.
7. The supply section does not record that endotoxin is not determined — arising from DRAFT-GHRP-6-MONOG/009. Section 8 now carries an explicit endotoxin line for every compound supplied in an injectable presentation, and states plainly that an undetermined attribute is undetermined rather than acceptable.
8. The mechanism section is written with more confidence than the clinical section it precedes — arising from DRAFT-GHRP-6-MONOG/010. Every pharmacology section now closes with a statement identifying which described actions are supported by clinical evidence assessed in §3 and which are not. The pharmacology itself is stated as the sources state it.
9. The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-GHRP-6-MONOG/011. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.

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

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