Consultation record
Submissions accepted — page 9
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 9 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-5-AMINO-1MQ-/001 | Draft monograph: 5-amino-1MQ | Quentin Gwynne-Sarpong | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-5-AMINO-1MQ-/002 | Draft monograph: 5-amino-1MQ | Dr Wolfram Kaltenbach-Mensah | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-AOD-9604-MON/009 | Draft monograph: AOD-9604 | Dr Anselm Mountstephen | What happens when the compound is stopped is not addressed |
| DRAFT-AOD-9604-MON/011 | Draft monograph: AOD-9604 | Dr Wilhelmina Erlingsson | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-AOD-9604-MON/012 | Draft monograph: AOD-9604 | Dr Adaeze Dunmore-Ekpo | Doses are expressed in units that differ between sections |
| DRAFT-AOD-9604-MON/006 | Draft monograph: AOD-9604 | Dr Piotr Hollingworth | The search date is not on the face of the document |
| DRAFT-AOD-9604-MON/014 | Draft monograph: AOD-9604 | Dr Gervase Crickhowell industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-AOD-9604-MON/016 | Draft monograph: AOD-9604 | Dr Oisín Marchetti-Bassey | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-AOD-9604-MON/010 | Draft monograph: AOD-9604 | Dr Wilhelmina Oppenheimer-Ade | Effect estimates are given without naming the comparator |
| DRAFT-CAGRILINTIDE/007 | Draft monograph: Cagrilintide | Dr Torvald Kettlewell | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-CAGRILINTIDE/013 | Draft monograph: Cagrilintide | Dr Ottoline Oppenheimer-Ade | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-CAGRILINTIDE/008 | Draft monograph: Cagrilintide | Dr Anselm Thorsby-Nakamura | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-CAGRILINTIDE/014 | Draft monograph: Cagrilintide | Dr Hortensia Larsson-Ekwueme | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-CAGRILINTIDE/006 | Draft monograph: Cagrilintide | Dr Mordecai Glendinning-Uche | What happens when the compound is stopped is not addressed |
| DRAFT-CAGRILINTIDE/005 | Draft monograph: Cagrilintide | Dr Vittoria Ylönen | Registered trials that never reported are absent from the monograph |
| DRAFT-CAGRILINTIDE/004 | Draft monograph: Cagrilintide | Dr Yaa Kettlewell industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-CAGRILINTIDE/010 | Draft monograph: Cagrilintide | Dr Anselm Ashworth-Danquah | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-CAGRILINTIDE/003 | Draft monograph: Cagrilintide | Vasilisa Sandringham-Adu | Effect estimates are given without naming the comparator |
| DRAFT-CAGRILINTIDE/011 | Draft monograph: Cagrilintide | Dr Theodora Ingelbrecht | The compound is supplied under names the monograph does not list |
| DRAFT-CAGRILINTIDE/002 | Draft monograph: Cagrilintide | Dr Lorcan Trelawney | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-CAGRISEMA-MO/003 | Draft monograph: CagriSema (cagrilintide with semaglutide) | Dr Séverine Oduya-Kaltenbrunner industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-CAGRISEMA-MO/001 | Draft monograph: CagriSema (cagrilintide with semaglutide) | Dr Emiliana Ollerenshaw | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-CAGRISEMA-MO/005 | Draft monograph: CagriSema (cagrilintide with semaglutide) | Dr Kolawole Isaksen-Balogun | Regulatory status is stated without naming the jurisdiction |
| DRAFT-CJC-1295-MON/004 | Draft monograph: CJC-1295 | Brigitta Grünbaum-Sowande | Effect estimates are given without naming the comparator |
| DRAFT-CJC-1295-MON/003 | Draft monograph: CJC-1295 | Dr Quentin Zimmerthal | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-CJC-1295-MON/012 | Draft monograph: CJC-1295 | Ms Rhiannon Okoye-Vandergraaf | Regulatory status is stated without naming the jurisdiction |
| DRAFT-CJC-1295-MON/001 | Draft monograph: CJC-1295 | Dr Eamon Sandringham-Adu | What happens when the compound is stopped is not addressed |
| DRAFT-CJC-1295-MON/007 | Draft monograph: CJC-1295 | Dr Lorcan Trelawney | The compound is supplied under names the monograph does not list |
| DRAFT-CJC-1295-MON/010 | Draft monograph: CJC-1295 | Professor Chukwuemeka Rasmussen-Adeyemi | Quantitative claims are reproduced without the method that produced them |
| DRAFT-CJC-1295-MON/005 | Draft monograph: CJC-1295 | Dr Yaa Kettlewell | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
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