Draft monograph: Glutathione — 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. Doses are expressed in units that differ between sections — arising from DRAFT-GLUTATHIONE-/012. 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.
2. Quantitative claims are reproduced without the method that produced them — arising from DRAFT-GLUTATHIONE-/008. 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.
3. The certainty rating for the principal assessed outcome cannot be traced to the contributing trials — arising from DRAFT-GLUTATHIONE-/011. 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. A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-GLUTATHIONE-/005. 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. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-GLUTATHIONE-/010. 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.
6. Effect estimates are given without naming the comparator — arising from DRAFT-GLUTATHIONE-/002. 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.
7. Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… — arising from DRAFT-GLUTATHIONE-/007. Cardiovascular outcomes are now an assessed outcome with their own certainty rating in every monograph for which a dedicated cardiovascular outcome trial of that compound has reported, and are recorded as not assessed elsewhere.
8. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-GLUTATHIONE-/001. 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…
9. The analytical section is longer than the clinical assessment it accompanies — arising from DRAFT-GLUTATHIONE-/004. 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.
10. The preclinical section is extensive and the clinical section is not — arising from DRAFT-GLUTATHIONE-/006. 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.
11. The recorded evidence gaps omit outcomes a reader would consider material — arising from DRAFT-GLUTATHIONE-/003. 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.
12. Trials are described as terminated where they completed as planned — arising from DRAFT-GLUTATHIONE-/013. 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.

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.