Consultation record
Submissions accepted — page 14
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 14 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-IPAMORELIN-M/002 | Draft monograph: Ipamorelin | Dr Yusuf Whitmarsh-Obi | Registered trials that never reported are absent from the monograph |
| DRAFT-IPAMORELIN-M/006 | Draft monograph: Ipamorelin | Dr Perpetua Haverkamp-Diallo industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-IPAMORELIN-M/007 | Draft monograph: Ipamorelin | Quentin Whitmarsh-Obi | The search date is not on the face of the document |
| DRAFT-IPAMORELIN-M/009 | Draft monograph: Ipamorelin | Professor Bartolomeu Nkosi-Lindegaard | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-IPAMORELIN-M/010 | Draft monograph: Ipamorelin | Dr Eamon Immelmann | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-KISSPEPTIN-1/001 | Draft monograph: Kisspeptin-10 | Dr Frideswide Grünbaum-Sowande | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-KPV-MONOGRAP/002 | Draft monograph: KPV | Dr Lorcan Zaleski-Mbeki | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-KPV-MONOGRAP/003 | Draft monograph: KPV | Dr Xenia Nyquist-Obiora | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-KPV-MONOGRAP/006 | Draft monograph: KPV | Dr Odalys Thorsby-Nakamura | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-KPV-MONOGRAP/007 | Draft monograph: KPV | Dr Gervase Abergavenny | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-KPV-MONOGRAP/009 | Draft monograph: KPV | Dr Melisande Kirkpatrick-Ola | Registered trials that never reported are absent from the monograph |
| DRAFT-KPV-MONOGRAP/012 | Draft monograph: KPV | Dr Quentin Zimmerthal | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-KPV-MONOGRAP/013 | Draft monograph: KPV | Dr Xiomara Fairweather-Duru | What happens when the compound is stopped is not addressed |
| DRAFT-KPV-MONOGRAP/014 | Draft monograph: KPV | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list |
| DRAFT-LARAZOTIDE-M/001 | Draft monograph: Larazotide acetate | Dr Jolanta Uttridge | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-LARAZOTIDE-M/002 | Draft monograph: Larazotide acetate | Dr Eamon Immelmann | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-LARAZOTIDE-M/004 | Draft monograph: Larazotide acetate | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-LARAZOTIDE-M/005 | Draft monograph: Larazotide acetate | Dr Ivo Quintanilha | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-LARAZOTIDE-M/006 | Draft monograph: Larazotide acetate | Dr Valentin Castellanos-Reid | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-LARAZOTIDE-M/008 | Draft monograph: Larazotide acetate | Dr Melisande Kirkpatrick-Ola | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-LIRAGLUTIDE-/001 | Draft monograph: Liraglutide | Dr Anselm Thorsby-Nakamura | Quantitative claims are reproduced without the method that produced them |
| DRAFT-LIRAGLUTIDE-/002 | Draft monograph: Liraglutide | Dr Liesbeth Zaleski-Mbeki | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-LIRAGLUTIDE-/003 | Draft monograph: Liraglutide | Dr Ottoline Fitzgerald-Nwosu | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-LIRAGLUTIDE-/004 | Draft monograph: Liraglutide | Dr Jacinta Grünbaum-Sowande | Glycaemic trials and weight-management trials are drawn on interchangeably |
| DRAFT-LIRAGLUTIDE-/006 | Draft monograph: Liraglutide | Dr Ndidi Ravensworth-Ilunga | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-LIRAGLUTIDE-/008 | Draft monograph: Liraglutide | Vittoria Ylönen | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-LIXISENATIDE/001 | Draft monograph: Lixisenatide | Dr Quentin Zimmerthal | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-LIXISENATIDE/003 | Draft monograph: Lixisenatide | Dr Lorcan Trelawney | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-LIXISENATIDE/004 | Draft monograph: Lixisenatide | Dr Quentin Enthoven | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-LIXISENATIDE/005 | Draft monograph: Lixisenatide | Dr Nikolai Yeovil-Bakare | A near-isobaric analogue is not distinguished by the identity determination described |
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