Consultation record
Submissions accepted — page 15
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 15 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-LIXISENATIDE/006 | Draft monograph: Lixisenatide | Dr Vittoria Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-LIXISENATIDE/010 | Draft monograph: Lixisenatide | Dr Nadezhda Lavrentiev | What happens to weight after the compound is stopped is not in the assessed outcomes |
| DRAFT-LL-37-MONOGR/004 | Draft monograph: LL-37 | Dr Matthias Whitmarsh-Obi | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-LL-37-MONOGR/005 | Draft monograph: LL-37 | Dr Quentin Zimmerthal | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-LL-37-MONOGR/006 | Draft monograph: LL-37 | Dr Evander Whitmarsh-Obi | Quantitative claims are reproduced without the method that produced them |
| DRAFT-MARIDEBART-C/001 | Draft monograph: Maridebart cafraglutide | Dr Hortensia Larsson-Ekwueme | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-MARIDEBART-C/002 | Draft monograph: Maridebart cafraglutide | Dr Jolanta Uttridge | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-MARIDEBART-C/003 | Draft monograph: Maridebart cafraglutide | Dr Evander Whitmarsh-Obi | Quantitative claims are reproduced without the method that produced them |
| DRAFT-MARIDEBART-C/004 | Draft monograph: Maridebart cafraglutide | Dr Ivo Quintanilha | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-MARIDEBART-C/005 | Draft monograph: Maridebart cafraglutide | Dr Jozef Brandvold-Achterberg | Registered trials that never reported are absent from the monograph |
| DRAFT-MARIDEBART-C/007 | Draft monograph: Maridebart cafraglutide | Dr Vasilisa Immelmann | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-MARIDEBART-C/008 | Draft monograph: Maridebart cafraglutide | Dr Eamon Immelmann | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-MARIDEBART-C/009 | Draft monograph: Maridebart cafraglutide | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-MAZDUTIDE-MO/003 | Draft monograph: Mazdutide | Dr Eamon Immelmann | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-MAZDUTIDE-MO/006 | Draft monograph: Mazdutide | Dr Jolanta Uttridge | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-MAZDUTIDE-MO/007 | Draft monograph: Mazdutide | Dr Leonhard Quenneville | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-MAZDUTIDE-MO/008 | Draft monograph: Mazdutide | Dr Vittoria Quintanilha | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-MAZDUTIDE-MO/009 | Draft monograph: Mazdutide | Dr Vasilisa Immelmann | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-MELANOTAN-II/002 | Draft monograph: Melanotan-II | Dr Hortensia Larsson-Ekwueme | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-MOTS-C-MONOG/002 | Draft monograph: MOTS-c | Dr Perpetua Haverkamp-Diallo industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-MOTS-C-MONOG/004 | Draft monograph: MOTS-c | Dr Melisande Kirkpatrick-Ola | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-MOTS-C-MONOG/006 | Draft monograph: MOTS-c | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-MOTS-C-MONOG/007 | Draft monograph: MOTS-c | Dr Valentin Tollemache | What happens when the compound is stopped is not addressed |
| DRAFT-MOTS-C-MONOG/008 | Draft monograph: MOTS-c | Dr Eamon Immelmann | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-NAD-PLUS-MON/002 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-NAD-PLUS-MON/003 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Ndidi Ravensworth-Ilunga | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-NAD-PLUS-MON/005 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Hortensia Larsson-Ekwueme | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-NAD-PLUS-MON/008 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Lorcan Trelawney | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-NAD-PLUS-MON/009 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Fitzwilliam Danquah-Öberg | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-ORAL-SEMAGLU/001 | Draft monograph: Semaglutide, oral | Dr Frideswide Nordhagen | Doses are expressed in units that differ between sections |
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