Consultation record
Submissions accepted — page 12
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 12 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-DSIP-MONOGRA/004 | Draft monograph: DSIP | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-DULAGLUTIDE-/002 | Draft monograph: Dulaglutide | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document |
| DRAFT-DULAGLUTIDE-/003 | Draft monograph: Dulaglutide | Dr Lorcan Zaleski-Mbeki | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-DULAGLUTIDE-/004 | Draft monograph: Dulaglutide | Dr Vittoria Quintanilha | Effect estimates are given without naming the comparator |
| DRAFT-DULAGLUTIDE-/005 | Draft monograph: Dulaglutide | Georgiana Zimmerthal | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-DULAGLUTIDE-/006 | Draft monograph: Dulaglutide | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-DULAGLUTIDE-/007 | Draft monograph: Dulaglutide | Dr Matthias Whitmarsh-Obi | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-DULAGLUTIDE-/008 | Draft monograph: Dulaglutide | Dr Eulalia Sonnenberg-Eze | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-DULAGLUTIDE-/009 | Draft monograph: Dulaglutide | Dr Ivo Quintanilha | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-DULAGLUTIDE-/010 | Draft monograph: Dulaglutide | Dr Melisande Kirkpatrick-Ola | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-DULAGLUTIDE-/011 | Draft monograph: Dulaglutide | Dr Henrike Jastrzębska | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-ECNOGLUTIDE-/001 | Draft monograph: Ecnoglutide | Dr Theodora Ingelbrecht | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-ECNOGLUTIDE-/002 | Draft monograph: Ecnoglutide | Dr Yusuf Whitmarsh-Obi | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-ECNOGLUTIDE-/004 | Draft monograph: Ecnoglutide | Dr Eamon Immelmann | The analytical section assumes a reference standard that is not generally available |
| DRAFT-ECNOGLUTIDE-/007 | Draft monograph: Ecnoglutide | Dr Ndidi Ravensworth-Ilunga | Registered trials that never reported are absent from the monograph |
| DRAFT-EPITHALON-MO/003 | Draft monograph: Epithalon | Dr Hyacinth Drakeford-Amadi | Doses are expressed in units that differ between sections |
| DRAFT-EPITHALON-MO/005 | Draft monograph: Epithalon | Dr Lorcan Trelawney | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-EXENATIDE-MO/002 | Draft monograph: Exenatide | Dr Piotr Hollingworth | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-EXENATIDE-MO/005 | Draft monograph: Exenatide | Professor Chukwuemeka Rasmussen-Adeyemi | What happens when the compound is stopped is not addressed |
| DRAFT-EXENATIDE-MO/006 | Draft monograph: Exenatide | Dr Leonhard Quenneville | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-EXENATIDE-MO/007 | Draft monograph: Exenatide | Dr Eamon Immelmann | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-GHK-CU-MONOG/001 | Draft monograph: GHK-Cu | Dr Valentin Tollemache | What happens when the compound is stopped is not addressed |
| DRAFT-GHK-CU-MONOG/002 | Draft monograph: GHK-Cu | Dr Ivo Quintanilha | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-GHK-CU-MONOG/007 | Draft monograph: GHK-Cu | Dr Radoslava Palmgren-Kofi | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-GHRP-2-MONOG/001 | Draft monograph: GHRP-2 | Dr Piotr Hollingworth | A rise in insulin-like growth factor 1 is reported in the position of a clinical outcome |
| DRAFT-GHRP-2-MONOG/002 | Draft monograph: GHRP-2 | Dr Ilona Mbatha-Fredriksen | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-GHRP-2-MONOG/005 | Draft monograph: GHRP-2 | Anselm Mountstephen | The compound is supplied under names the monograph does not list |
| DRAFT-GHRP-2-MONOG/007 | Draft monograph: GHRP-2 | Dr Ivo Quintanilha | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-GHRP-6-MONOG/002 | Draft monograph: GHRP-6 | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-GHRP-6-MONOG/005 | Draft monograph: GHRP-6 | Dr Evander Whitmarsh-Obi | The analytical section assumes a reference standard that is not generally available |
page 12 of 25