Consultation record
Submissions accepted — page 11
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.
Submissions
735 documents · page 11 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-AOD-9604-MON/003 | Draft monograph: AOD-9604 | Ivo Mountstephen | The search date is not on the face of the document |
| DRAFT-AOD-9604-MON/005 | Draft monograph: AOD-9604 | Dr Theodora Ingelbrecht | A rise in insulin-like growth factor 1 is reported in the position of a clinical outcome |
| DRAFT-AOD-9604-MON/007 | Draft monograph: AOD-9604 | Dr Ottoline Fitzgerald-Nwosu | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-AOD-9604-MON/008 | Draft monograph: AOD-9604 | Dr Emiliana Ollerenshaw | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-AOD-9604-MON/010 | Draft monograph: AOD-9604 | Dr Quentin Zimmerthal | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-AOD-9604-MON/012 | Draft monograph: AOD-9604 | Dr Valentin Castellanos-Reid | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-AOD-9604-MON/014 | Draft monograph: AOD-9604 | Dr Vittoria Quintanilha | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-AOD-9604-MON/015 | Draft monograph: AOD-9604 | Dr Hyacinth Oyelaran-Steen | What happens when the compound is stopped is not addressed |
| DRAFT-AOD-9604-MON/016 | Draft monograph: AOD-9604 | Dr Yusuf Whitmarsh-Obi | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-CAGRILINTIDE/001 | Draft monograph: Cagrilintide | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-CAGRILINTIDE/002 | Draft monograph: Cagrilintide | Dr Xiomara Fairweather-Duru | What happens to weight after the compound is stopped is not in the assessed outcomes |
| DRAFT-CAGRILINTIDE/004 | Draft monograph: Cagrilintide | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-CAGRILINTIDE/005 | Draft monograph: Cagrilintide | Eamon Sandringham-Adu | The compound is supplied under names the monograph does not list |
| DRAFT-CAGRILINTIDE/006 | Draft monograph: Cagrilintide | Dr Anselm Thorsby-Nakamura | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-CAGRILINTIDE/011 | Draft monograph: Cagrilintide | Dr Melisande Kirkpatrick-Ola | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-CAGRILINTIDE/012 | Draft monograph: Cagrilintide | Dr Brigitta Grünbaum-Sowande | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-CAGRILINTIDE/014 | Draft monograph: Cagrilintide | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-CAGRILINTIDE/015 | Draft monograph: Cagrilintide | Dr Liesbeth Nyquist-Obiora | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-CAGRILINTIDE/016 | Draft monograph: Cagrilintide | Dr Rurik Underhill-Okafor | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-CAGRISEMA-MO/001 | Draft monograph: CagriSema (cagrilintide with semaglutide) | Dr Fitzwilliam Danquah-Öberg | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-CAGRISEMA-MO/002 | Draft monograph: CagriSema (cagrilintide with semaglutide) | Dr Henrike Jastrzębska | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-CAGRISEMA-MO/005 | Draft monograph: CagriSema (cagrilintide with semaglutide) | Dr Lorcan Trelawney | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-CJC-1295-MON/001 | Draft monograph: CJC-1295 | Dr Vasilisa Immelmann | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-CJC-1295-MON/003 | Draft monograph: CJC-1295 | Dr Fitzwilliam Danquah-Öberg | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-CJC-1295-MON/004 | Draft monograph: CJC-1295 | Dr Valentin Tollemache | What happens when the compound is stopped is not addressed |
| DRAFT-CJC-1295-MON/005 | Draft monograph: CJC-1295 | Dr Adaeze Underhill-Okafor | Registered trials that never reported are absent from the monograph |
| DRAFT-CJC-1295-MON/007 | Draft monograph: CJC-1295 | Dr Evander Whitmarsh-Obi | The analytical section assumes a reference standard that is not generally available |
| DRAFT-CJC-1295-MON/009 | Draft monograph: CJC-1295 | Ivo Mountstephen | The compound is supplied under names the monograph does not list |
| DRAFT-CJC-1295-MON/012 | Draft monograph: CJC-1295 | Dr Ivo Quintanilha | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-DSIP-MONOGRA/002 | Draft monograph: DSIP | Dr Quentin Gwynne-Sarpong | The population to which the headline estimate applies is not stated with the estimate |
page 11 of 25