Draft monograph: Selank — submissions
The 8 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
8 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
The document set should be published in translation
The respondent read the draft on Selank and has confined this submission to a single matter.
The respondent notes that the assessments concern compounds supplied internationally and that publishing only in English restricts access to the assessment to readers who work in it.
The respondent proposes machine translation of the document set as an interim measure, with human review of the certainty language.
The secretariat does not accept this submission, and records that the underlying point is sound and that the proposed remedy is the difficulty.
A translation whose certainty language has drifted is a different assessment carrying the Institute's name, and the Institute cannot review translations it does not have the capacity to review. The documents remain in English. The submission is published in full because the access problem it identifies is real and unresolved.
The route of administration studied is not the route in which the compound is supplied
Having read the draft monograph on Selank, the respondent puts one point to the committee.
The clinical section describes findings obtained by one route and the supply section describes presentations intended for another. A reader moving between the two sections will carry the effect estimate across the change without noticing that it has been carried, because nothing on the page marks the transition.
The respondent proposes that where the studied route and the supplied presentation differ, the difference be stated in the assessed-outcome table itself rather than in the supply section, on the ground that a reader consults the outcome table and does not always reach §8.
The respondent endorses the general approach taken in submission 001 and asks that it be extended to the matter identified here.
The secretariat accepts this submission. The route by which an estimate was generated is a condition of the estimate and belongs beside it.
The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
The monograph should state what the compound costs
This is a submission on Selank.
The respondent states that a reader deciding whether to pursue treatment needs to know what it costs, and that omitting price makes the assessment less useful than it could be.
The respondent proposes that a price range be recorded for each compound with the source and date.
The secretariat does not accept this submission. Price varies by jurisdiction, payer, presentation and date to a degree that no single figure could survive, and a stale price is worse than no price.
No price is recorded. The monograph records the presentations available and the regulatory status in each jurisdiction, which are the facts the Institute can verify and maintain. The submission remains published in full.
The interaction section lists mechanisms rather than interactions
Having read the draft under consultation, which concerns Selank, the respondent submits as follows.
The section describes pathways by which an interaction could occur. It does not say which interactions have been observed, in what setting, or with what consequence. A reader dispensing alongside other therapy cannot act on a mechanism.
The respondent proposes that observed interactions be separated from theoretical ones, and that the theoretical ones be labelled as such.
The secretariat accepts the separation and declines to expand the section beyond the evidence.
The interaction section is now divided into interactions reported in clinical use and interactions predicted from mechanism, with the second labelled as prediction. Where neither exists the section says so in one line rather than being padded.
A near-isobaric analogue is not distinguished by the identity determination described
The respondent submits on the draft monograph for Selank. A neuroactive peptide raises a question the reader wants answered early, which is whether the compound reaches the compartment in which it is said to act.
The identity determination described in the draft resolves the compound from unrelated substances but would not distinguish it from a closely related analogue whose mass differs by approximately one dalton.
The respondent proposes that the monograph state the resolution required for that discrimination, and state that a nominal-mass instrument reporting an integer mass has not made it.
The secretariat accepts this submission. The point is decisive where one member of a near-isobaric pair is an approved medicine and the other is not.
The analytical section now states the resolving power required to discriminate the pair, names the pair explicitly, and records that an identity claim made below that resolution is not conformant with the identity standard.
The monograph should reproduce the approved labelling rather than paraphrase it
The respondent notes that much of the source literature for Selank is published in one national literature, and submits with that in view.
The submission is made on behalf of the marketing-authorisation holder. It states that the draft paraphrases the approved indication, the posology and the contraindications, and that any paraphrase risks diverging from the authorised text.
The sponsor asks that the authorised wording be reproduced verbatim in each case, and offers the current summary of product characteristics as the source.
The secretariat accepts this submission in part. The authorised indication and the contraindications are reproduced verbatim and attributed. The posology is not, because the monograph reports what the trials administered as well as what the labelling authorises, and the two are frequently different.
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.
The monograph does not tell a reader that two vials of the same compound may not contain the same thing
The respondent has read the draft covering Selank and makes one submission.
The analytical section describes what a determination measures and the supply section describes what suppliers document. Neither says that the quantity of peptide in two vials bearing the same label may differ by more than the difference between two doses in the trial schedule.
The respondent proposes an explicit statement, in §8, that a purity figure describes the lot it was measured on and nothing else, and that the practical consequence is that a dose calculated from a label is an estimate.
This submission is made in the same spirit as submission 004 and on a different aspect of the draft.
The secretariat accepts this submission. It is the single most consequential thing a reader of this series can be told and it was distributed across three sections rather than stated once.
A standing paragraph now appears at the head of §8 in every monograph, stating that a determination applies to the lot measured and that a label mass is not a determination.
The monograph should not describe how the compound is supplied outside a regulated route
The respondent has read Selank in draft and makes a single submission.
The respondent states that describing presentations observed in unregulated supply risks being read as a guide to obtaining them, and asks that the material be removed.
The respondent accepts that the information is accurate and objects to its presence rather than to its content.
The secretariat notes this submission and records the concern as a real one that the draft had already considered.
No amendment arises. The monograph describes what is supplied and names no supplier, price or route of acquisition, and it carries the standing statement that the Institute assesses evidence and does not recommend use. Describing a presentation a reader may already hold is the condition of being useful to that reader.
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.
- 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.