Consultation record
Submissions accepted — page 13
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
681 documents · page 13 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-LIXISENATIDE/003 | Draft monograph: Lixisenatide | Xiomara Fairweather-Duru | Quantitative claims are reproduced without the method that produced them |
| DRAFT-LIXISENATIDE/002 | Draft monograph: Lixisenatide | Dr Ndidi Ravensworth-Ilunga | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-LL-37-MONOGR/005 | Draft monograph: LL-37 | Dr Hamish Nyquist-Obiora | Quantitative claims are reproduced without the method that produced them |
| DRAFT-LL-37-MONOGR/002 | Draft monograph: LL-37 | Dr Wilhelmina Wintringham | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-LL-37-MONOGR/003 | Draft monograph: LL-37 | Dr Fenella Lavrentiev | The same concept is given three different names in one document |
| DRAFT-LL-37-MONOGR/004 | Draft monograph: LL-37 | Ludmila Brackenridge | The analytical section assumes a reference standard that is not generally available |
| DRAFT-MARIDEBART-C/002 | Draft monograph: Maridebart cafraglutide | Professor Ekaterina Voskresenskaya-Hill | Registered trials that never reported are absent from the monograph |
| DRAFT-MARIDEBART-C/007 | Draft monograph: Maridebart cafraglutide | Dr Quentin Enthoven | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-MARIDEBART-C/004 | Draft monograph: Maridebart cafraglutide | Dr Amara Vandergraaf | The analytical section assumes a reference standard that is not generally available |
| DRAFT-MARIDEBART-C/009 | Draft monograph: Maridebart cafraglutide | Dr Georgiana Mountstephen | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-MARIDEBART-C/003 | Draft monograph: Maridebart cafraglutide | Dr Hyacinth Oyelaran-Steen | The same concept is given three different names in one document |
| DRAFT-MARIDEBART-C/005 | Draft monograph: Maridebart cafraglutide | Dr Liesbeth Achterberg | Quantitative claims are reproduced without the method that produced them |
| DRAFT-MAZDUTIDE-MO/003 | Draft monograph: Mazdutide | Dr Séverin Oppenheimer-Ade | Quantitative claims are reproduced without the method that produced them |
| DRAFT-MAZDUTIDE-MO/007 | Draft monograph: Mazdutide | Dr Vittoria Ylönen | Regulatory status is stated without naming the jurisdiction |
| DRAFT-MAZDUTIDE-MO/001 | Draft monograph: Mazdutide | Vasilisa Sandringham-Adu | The compound is supplied under names the monograph does not list |
| DRAFT-MAZDUTIDE-MO/006 | Draft monograph: Mazdutide | Dr Anselm Thorsby-Nakamura | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-MAZDUTIDE-MO/009 | Draft monograph: Mazdutide | Dr Abimbola Sotomayor-Ekwueme | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-MAZDUTIDE-MO/008 | Draft monograph: Mazdutide | Dr Mordecai Glendinning-Uche | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-MAZDUTIDE-MO/005 | Draft monograph: Mazdutide | Dr Torvald Kettlewell | The same concept is given three different names in one document |
| DRAFT-MELANOTAN-II/001 | Draft monograph: Melanotan-II | Dr Emiliana Ollerenshaw | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-MELANOTAN-II/002 | Draft monograph: Melanotan-II | Dr Quentin Enthoven | The same concept is given three different names in one document |
| DRAFT-MOTS-C-MONOG/003 | Draft monograph: MOTS-c | Dr Beatrijs Hazelrigg | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-MOTS-C-MONOG/004 | Draft monograph: MOTS-c | Dr Georgiana Zimmerthal | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-MOTS-C-MONOG/001 | Draft monograph: MOTS-c | Dr Yolanda Norrington-Bhatt | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-MOTS-C-MONOG/002 | Draft monograph: MOTS-c | Dr Yehudit Quaresma | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-MOTS-C-MONOG/006 | Draft monograph: MOTS-c | Sigrún Vercingetorix industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-MOTS-C-MONOG/008 | Draft monograph: MOTS-c | Dr Anselm Mountstephen | What happens when the compound is stopped is not addressed |
| DRAFT-NAD-PLUS-MON/006 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Ivo Quintanilha | Effect estimates are given without naming the comparator |
| DRAFT-NAD-PLUS-MON/005 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Katarzyna Oppenheimer-Ade industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-NAD-PLUS-MON/007 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Mordecai Glendinning-Uche | What happens when the compound is stopped is not addressed |
page 13 of 23