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
681 documents · page 12 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-IPAMORELIN-M/008 | Draft monograph: Ipamorelin | Ivo Mountstephen | Effect estimates are given without naming the comparator |
| DRAFT-IPAMORELIN-M/009 | Draft monograph: Ipamorelin | Dr Jerome Lavrentiev | What happens when the compound is stopped is not addressed |
| DRAFT-IPAMORELIN-M/002 | Draft monograph: Ipamorelin | Dr Theodora Trelawney | Quantitative claims are reproduced without the method that produced them |
| DRAFT-IPAMORELIN-M/003 | Draft monograph: Ipamorelin | Dr Quentin Zimmerthal | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-KISSPEPTIN-1/001 | Draft monograph: Kisspeptin-10 | Dr Kolawole Isaksen-Balogun | The analytical section assumes a reference standard that is not generally available |
| DRAFT-KISSPEPTIN-1/002 | Draft monograph: Kisspeptin-10 | Dr Lorcan Whitmarsh-Obi | The same concept is given three different names in one document |
| DRAFT-KPV-MONOGRAP/001 | Draft monograph: KPV | Dr Nikolai Yeovil-Bakare | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-KPV-MONOGRAP/002 | Draft monograph: KPV | Dr Evander Whitmarsh-Obi | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-KPV-MONOGRAP/009 | Draft monograph: KPV | Dr Wojciech Kaltenbach-Mensah | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-KPV-MONOGRAP/011 | Draft monograph: KPV | Dr Rosalind Grünbaum-Sowande | Regulatory status is stated without naming the jurisdiction |
| DRAFT-KPV-MONOGRAP/004 | Draft monograph: KPV | Kolawole Oppenheimer-Ade | What happens when the compound is stopped is not addressed |
| DRAFT-KPV-MONOGRAP/007 | Draft monograph: KPV | Professor Chukwuemeka Rasmussen-Adeyemi | Registered trials that never reported are absent from the monograph |
| DRAFT-KPV-MONOGRAP/015 | Draft monograph: KPV | Xenia Nyquist-Obiora | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-KPV-MONOGRAP/006 | Draft monograph: KPV | Dr Frideswide Grünbaum-Sowande | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-LARAZOTIDE-M/001 | Draft monograph: Larazotide acetate | Nkechi Larsson-Ekwueme | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-LARAZOTIDE-M/007 | Draft monograph: Larazotide acetate | Dr Rurik Underhill-Okafor | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-LARAZOTIDE-M/006 | Draft monograph: Larazotide acetate | Dr Oisín Marchetti-Bassey industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-LARAZOTIDE-M/002 | Draft monograph: Larazotide acetate | Vittoria Quintanilha | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-LARAZOTIDE-M/008 | Draft monograph: Larazotide acetate | Xenia Nyquist-Obiora | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-LARAZOTIDE-M/004 | Draft monograph: Larazotide acetate | Dr Ndidi Ravensworth-Ilunga | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-LIRAGLUTIDE-/004 | Draft monograph: Liraglutide | Dr Kamila Glendinning-Uche | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-LIRAGLUTIDE-/003 | Draft monograph: Liraglutide | Zdenka Ximenes | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-LIRAGLUTIDE-/007 | Draft monograph: Liraglutide | Dr Henrike Jastrzębska | Regulatory status is stated without naming the jurisdiction |
| DRAFT-LIRAGLUTIDE-/006 | Draft monograph: Liraglutide | Dr Quintus Rautavaara | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-LIRAGLUTIDE-/001 | Draft monograph: Liraglutide | Dr Liesbeth Zaleski-Mbeki industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-LIRAGLUTIDE-/002 | Draft monograph: Liraglutide | Dr Eamon Immelmann | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-LIXISENATIDE/009 | Draft monograph: Lixisenatide | Ignatius Erlingsson | Effect estimates are given without naming the comparator |
| DRAFT-LIXISENATIDE/006 | Draft monograph: Lixisenatide | Xenia Nyquist-Obiora | The compound is supplied under names the monograph does not list |
| DRAFT-LIXISENATIDE/005 | Draft monograph: Lixisenatide | Dr Rurik Underhill-Okafor | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-LIXISENATIDE/008 | Draft monograph: Lixisenatide | Vittoria Quintanilha | What happens when the compound is stopped is not addressed |
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