Public comment period · §3
Draft monograph: LL-37 — disposition
The disposition of every submission and the amendments that resulted.
§3Disposition and amendments
§3.1Disposition table
Table 1. Every submission with its disposition. Each row links to the submission in full.
| Reference | Respondent | Point raised | Disposition |
|---|---|---|---|
| DRAFT-LL-37-MONOGR/001 | Vittoria Ylönen | The monograph should not describe how the compound is supplied outside a regulated route | Noted, no amendment |
| DRAFT-LL-37-MONOGR/002 | Dr Theodora Ingelbrecht | The document should state what a reader ought to do | Not accepted |
| DRAFT-LL-37-MONOGR/003 | Dr Lorcan Uttridge | Anti-drug antibody data are omitted | Accepted in part |
| DRAFT-LL-37-MONOGR/004 | Dr Matthias Whitmarsh-Obi | Nothing is said about impaired renal or hepatic clearance | Accepted |
| DRAFT-LL-37-MONOGR/005 | Dr Quentin Zimmerthal | The monograph does not tell a reader that two vials of the same compound may not contain the same thing | Accepted |
| DRAFT-LL-37-MONOGR/006 | Dr Evander Whitmarsh-Obi | Quantitative claims are reproduced without the method that produced them | Accepted |
| 6 submissions in total. | |||
§3.2Summary by disposition
Table 2. Counts by disposition, with the meaning of each.
| Disposition | Count | Meaning |
|---|---|---|
| Accepted | 3 | The submission is accepted and the draft is amended as proposed. The amendment is recorded in the amendment log of the document it changed and is traceable to the numbered submission. |
| Accepted in part | 1 | Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined. |
| Noted, no amendment | 1 | The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response. |
| Not accepted | 1 | The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it. |
§3.3Resulting amendments
- Anti-drug antibody data are omitted — arising from DRAFT-LL-37-MONOGR/003. 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.
- Nothing is said about impaired renal or hepatic clearance — arising from DRAFT-LL-37-MONOGR/004. The pharmacokinetic table now carries renal and hepatic rows in every monograph, populated with the study where one exists and with an explicit statement of absence where none does.
- The monograph does not tell a reader that two vials of the same compound may not contain the same… — arising from DRAFT-LL-37-MONOGR/005. 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.
- Quantitative claims are reproduced without the method that produced them — arising from DRAFT-LL-37-MONOGR/006. 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.
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.
Compound Evidence Institute · CEI-CP-063/3 · https://compoundevidence.com/comment-periods/draft-ll-37-monograph/disposition/ · retrieved 30 July 2026