Draft monograph: Semax — 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. Open-label extension data are presented alongside randomised data without distinction — arising from DRAFT-SEMAX-MONOGR/001. Extension data now appear in a separate table headed as uncontrolled follow-up, with a standing note on differential withdrawal.
2. The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-SEMAX-MONOGR/002. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
3. Evidence for one member of the class is presented as evidence for this compound — arising from DRAFT-SEMAX-MONOGR/003. Class-level inferences are now labelled at the point of use, are excluded from the certainty rating for the compound, and are reported in a separate subsection stating which compound the underlying evidence concerns.
4. Effect estimates are given without naming the comparator — arising from DRAFT-SEMAX-MONOGR/006. 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.
5. The compound is supplied under names the monograph does not list — arising from DRAFT-SEMAX-MONOGR/007. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
6. Absence of evidence is presented in a form a reader will take as negative evidence — arising from DRAFT-SEMAX-MONOGR/008. 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…
7. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-SEMAX-MONOGR/009. 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.
8. Preclinical findings are reported without the model that produced them — arising from DRAFT-SEMAX-MONOGR/010. Every preclinical statement in the series now carries the model and, where the source reports it, the dose and the route.
9. The population to which the headline estimate applies is not stated with the estimate — arising from DRAFT-SEMAX-MONOGR/011. Every headline estimate now carries a one-line statement of the population in which it was observed, and the full eligibility criteria are reported in the included-studies table rather than only in the source.
10. Regulatory status is stated without naming the jurisdiction — arising from DRAFT-SEMAX-MONOGR/012. 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.
11. The preclinical section is extensive and the clinical section is not — arising from DRAFT-SEMAX-MONOGR/013. 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.
12. The monograph should reproduce the approved labelling rather than paraphrase it — arising from DRAFT-SEMAX-MONOGR/014. 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.
13. The same concept is given three different names in one document — arising from DRAFT-SEMAX-MONOGR/015. 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.

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.