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
735 documents · page 13 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-GHRP-6-MONOG/006 | Draft monograph: GHRP-6 | Dr Vittoria Quintanilha | Registered trials that never reported are absent from the monograph |
| DRAFT-GHRP-6-MONOG/007 | Draft monograph: GHRP-6 | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document |
| DRAFT-GHRP-6-MONOG/009 | Draft monograph: GHRP-6 | Dr Katarzyna Oppenheimer-Ade | The supply section does not record that endotoxin is not determined |
| DRAFT-GHRP-6-MONOG/011 | Draft monograph: GHRP-6 | Dr Liesbeth Nyquist-Obiora | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-GLUTATHIONE-/002 | Draft monograph: Glutathione | Dr Adaeze Underhill-Okafor | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-GLUTATHIONE-/004 | Draft monograph: Glutathione | Dr Hyacinth Oyelaran-Steen | What happens when the compound is stopped is not addressed |
| DRAFT-GLUTATHIONE-/005 | Draft monograph: Glutathione | Dr Odalys Thorsby-Nakamura | Registered trials that never reported are absent from the monograph |
| DRAFT-GLUTATHIONE-/008 | Draft monograph: Glutathione | Dr Ivo Quintanilha | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-GLUTATHIONE-/009 | Draft monograph: Glutathione | Dr Ottoline Fitzgerald-Nwosu | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-GLUTATHIONE-/010 | Draft monograph: Glutathione | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-GLUTATHIONE-/011 | Draft monograph: Glutathione | Dr Marisol Dunmore-Ekpo | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-GLUTATHIONE-/012 | Draft monograph: Glutathione | Dr Anselm Thorsby-Nakamura | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-GLUTATHIONE-/014 | Draft monograph: Glutathione | Dr Kamila Glendinning-Uche | Preclinical findings are reported without the model that produced them |
| DRAFT-GONADORELIN-/002 | Draft monograph: Gonadorelin | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list |
| DRAFT-GONADORELIN-/004 | Draft monograph: Gonadorelin | Dr Zdenka Ximenes | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-GONADORELIN-/005 | Draft monograph: Gonadorelin | Dr Fenella Lavrentiev | The difference between pulsatile and continuous administration is not addressed |
| DRAFT-GONADORELIN-/006 | Draft monograph: Gonadorelin | Dr Eamon Immelmann | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-GONADORELIN-/007 | Draft monograph: Gonadorelin | Dr Quentin Zimmerthal | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-GONADORELIN-/008 | Draft monograph: Gonadorelin | Dr Abimbola Sotomayor-Ekwueme | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-GONADORELIN-/009 | Draft monograph: Gonadorelin | Dr Ivo Quintanilha | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-HEXARELIN-MO/002 | Draft monograph: Hexarelin | Dr Theodora Ingelbrecht | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-HEXARELIN-MO/003 | Draft monograph: Hexarelin | Dr Fitzwilliam Danquah-Öberg | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-HEXARELIN-MO/005 | Draft monograph: Hexarelin | Ivo Mountstephen | The search date is not on the face of the document |
| DRAFT-HEXARELIN-MO/007 | Draft monograph: Hexarelin | Dr Henrike Jastrzębska | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-IGF-1-LR3-MO/001 | Draft monograph: IGF-1 LR3 | Dr Ngozi Zetterlund | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-IGF-1-LR3-MO/002 | Draft monograph: IGF-1 LR3 | Dr Marisol Dunmore-Ekpo | Registered trials that never reported are absent from the monograph |
| DRAFT-IGF-1-LR3-MO/003 | Draft monograph: IGF-1 LR3 | Dr Lorcan Trelawney | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-IGF-1-LR3-MO/005 | Draft monograph: IGF-1 LR3 | Dr Constança Glendinning-Uche | The same concept is given three different names in one document |
| DRAFT-IGF-1-LR3-MO/007 | Draft monograph: IGF-1 LR3 | Dr Evander Whitmarsh-Obi | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-IGF-1-LR3-MO/009 | Draft monograph: IGF-1 LR3 | Dr Quentin Zimmerthal | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
page 13 of 25