Draft monograph: Thymalin — 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. Anti-drug antibody data are omitted — arising from DRAFT-THYMALIN-MON/002. 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.
2. Doses are expressed in units that differ between sections — arising from DRAFT-THYMALIN-MON/003. 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.
3. The pharmacokinetic section does not connect half-life to the dosing schedule — arising from DRAFT-THYMALIN-MON/004. The pharmacokinetic section now states approximate time to steady state alongside the half-life and dosing interval, with the assumption of first-order elimination stated, and records where the assumption is not supported for this compound.
4. The preclinical section is extensive and the clinical section is not — arising from DRAFT-THYMALIN-MON/005. 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.
5. Point estimates are given without an interval — arising from DRAFT-THYMALIN-MON/006. 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.
6. Trials are described as terminated where they completed as planned — arising from DRAFT-THYMALIN-MON/007. 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.
7. The document is unreadable without specialist training — arising from DRAFT-THYMALIN-MON/008. 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.
8. The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-THYMALIN-MON/009. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
9. Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… — arising from DRAFT-THYMALIN-MON/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.

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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