Consultation record
Submissions accepted — page 11
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 11 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-GHRP-2-MONOG/003 | Draft monograph: GHRP-2 | Dr Hyacinth Drakeford-Amadi | Registered trials that never reported are absent from the monograph |
| DRAFT-GHRP-2-MONOG/006 | Draft monograph: GHRP-2 | Dr Nikolai Yeovil-Bakare | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-GHRP-2-MONOG/005 | Draft monograph: GHRP-2 | Dr Evander Whitmarsh-Obi | Doses are expressed in units that differ between sections |
| DRAFT-GHRP-6-MONOG/002 | Draft monograph: GHRP-6 | Dr Amara Quaresma | The same concept is given three different names in one document |
| DRAFT-GHRP-6-MONOG/007 | Draft monograph: GHRP-6 | Dr Dmitri Nordhagen | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-GHRP-6-MONOG/006 | Draft monograph: GHRP-6 | Dr Zebedee Zaleski-Mbeki | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-GHRP-6-MONOG/008 | Draft monograph: GHRP-6 | Dr Liesbeth Quenneville | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-GHRP-6-MONOG/005 | Draft monograph: GHRP-6 | Dr Ottoline Fitzgerald-Nwosu | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-GLUTATHIONE-/012 | Draft monograph: Glutathione | Dr Séverine Oduya-Kaltenbrunner | Doses are expressed in units that differ between sections |
| DRAFT-GLUTATHIONE-/008 | Draft monograph: Glutathione | Xiomara Fairweather-Duru | Quantitative claims are reproduced without the method that produced them |
| DRAFT-GLUTATHIONE-/011 | Draft monograph: Glutathione | Dr Liesbeth Achterberg | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-GLUTATHIONE-/005 | Draft monograph: Glutathione | Ms Rhiannon Okoye-Vandergraaf | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-GLUTATHIONE-/010 | Draft monograph: Glutathione | Leonhard Achterberg | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-GLUTATHIONE-/002 | Draft monograph: Glutathione | Dr Leonhard Quenneville | Effect estimates are given without naming the comparator |
| DRAFT-GLUTATHIONE-/001 | Draft monograph: Glutathione | Dr Ilona Mbatha-Fredriksen | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-GONADORELIN-/002 | Draft monograph: Gonadorelin | Gaspard Kettlewell | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-GONADORELIN-/001 | Draft monograph: Gonadorelin | Valentin Tollemache | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-GONADORELIN-/006 | Draft monograph: Gonadorelin | Dr Nikolai Yeovil-Bakare | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-GONADORELIN-/008 | Draft monograph: Gonadorelin | Dr Jozef Brandvold-Achterberg | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-GONADORELIN-/004 | Draft monograph: Gonadorelin | Dr Fitzwilliam Danquah-Öberg | Effect estimates are given without naming the comparator |
| DRAFT-GONADORELIN-/003 | Draft monograph: Gonadorelin | Adaeze Underhill-Okafor | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-HEXARELIN-MO/005 | Draft monograph: Hexarelin | Sigrún Vercingetorix | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-HEXARELIN-MO/006 | Draft monograph: Hexarelin | Dr Odalys Thorsby-Nakamura industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-HEXARELIN-MO/001 | Draft monograph: Hexarelin | Dr Oisín Rautavaara | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-IGF-1-LR3-MO/005 | Draft monograph: IGF-1 LR3 | Dr Katarzyna Oppenheimer-Ade | The absence of a rare harm in the trial set is presented as reassurance |
| DRAFT-IGF-1-LR3-MO/008 | Draft monograph: IGF-1 LR3 | Dr Bertrand Steenkamp-Ferreira | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-IGF-1-LR3-MO/007 | Draft monograph: IGF-1 LR3 | Dr Anselm Ashworth-Danquah | Doses are expressed in units that differ between sections |
| DRAFT-IGF-1-LR3-MO/002 | Draft monograph: IGF-1 LR3 | Dr Torvald Kettlewell | Quantitative claims are reproduced without the method that produced them |
| DRAFT-IGF-1-LR3-MO/009 | Draft monograph: IGF-1 LR3 | Dr Vasilisa Immelmann | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-IPAMORELIN-M/007 | Draft monograph: Ipamorelin | Dr Wilhelmina Quaresma | The population to which the headline estimate applies is not stated with the estimate |
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