Consultation record
Submissions noted, no amendment — page 4
The submission raises a point the Institute accepts but that does not require a change to the draft, most often because the draft already states it elsewhere. The location is given in the response.
Submissions
127 documents · page 4 of 5
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-SERMORELIN-M/007 | Draft monograph: Sermorelin | Dr Anselm Ashworth-Danquah | A superseded version should remain reachable from the version that replaced it |
| DRAFT-SS-31-MONOGR/009 | Draft monograph: SS-31 (elamipretide) | Dr Torvald Kettlewell | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-SS-31-MONOGR/006 | Draft monograph: SS-31 (elamipretide) | Dr Ulysses Bellingham-Ojo | A superseded version should remain reachable from the version that replaced it |
| DRAFT-TB-500-MONOG/006 | Draft monograph: TB-500 | Xiomara Fairweather-Duru | A superseded version should remain reachable from the version that replaced it |
| DRAFT-TESAMORELIN-/010 | Draft monograph: Tesamorelin | Dr Theodora Ximenes | A superseded version should remain reachable from the version that replaced it |
| DRAFT-THYMALIN-MON/001 | Draft monograph: Thymalin | Dr Nadezhda Lavrentiev | A superseded version should remain reachable from the version that replaced it |
| DRAFT-THYMOSIN-ALP/007 | Draft monograph: Thymosin alpha-1 | Dr Melisande Thorsby-Nakamura | A sortable table implies a comparison the underlying data do not support |
| DRAFT-PEPTIDE-CONT/009 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Gervase Abergavenny | Declared interests should appear on the document rather than on a separate page |
| DRAFT-RELATED-SUBS/004 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Ilona Mbatha-Fredriksen | A sortable table implies a comparison the underlying data do not support |
| DRAFT-RELATED-SUBS/007 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Liesbeth Achterberg | Declared interests should appear on the document rather than on a separate page |
| DRAFT-COUNTER-ION-/013 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Wilhelmina Quaresma | A superseded version should remain reachable from the version that replaced it |
| DRAFT-AGGREGATES-S/011 | Draft standard CEI-MS-11: Determination of aggregate content by… | Ignatius Erlingsson | Declared interests should appear on the document rather than on a separate page |
| DRAFT-STABILITY-IN/002 | Draft standard CEI-MS-13: Development and validation of a… | Nkechi Larsson-Ekwueme | Declared interests should appear on the document rather than on a separate page |
| DRAFT-THIRD-PARTY-/002 | Draft standard CEI-MS-15: Protocol for independent third-party… | Dr Yehudit Quaresma | A sortable table implies a comparison the underlying data do not support |
| DRAFT-APPEARANCE-S/006 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Dr Georgiana Zimmerthal | A sortable table implies a comparison the underlying data do not support |
| DRAFT-POORLY-RETAI/001 | Draft standard CEI-MS-19: Purity determination for peptides not… | Dr Theodora Ximenes | A superseded version should remain reachable from the version that replaced it |
| DRAFT-INCRETIN-CAR/002 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Quentin Gwynne-Sarpong | A sortable table implies a comparison the underlying data do not support |
| DRAFT-ORAL-VS-INJE/005 | Draft synthesis: Oral compared with injectable presentations of… | Dr Dmitri Nordhagen | A superseded version should remain reachable from the version that replaced it |
| DRAFT-HFPEF-INCRET/001 | Draft synthesis: Incretin receptor agonists in heart failure with… | Dr Vasilisa Immelmann | A sortable table implies a comparison the underlying data do not support |
| DRAFT-SLEEP-APNOEA/002 | Draft synthesis: Weight-reducing agents for obstructive sleep apnoea | Radoslava Palmgren-Kofi | A sortable table implies a comparison the underlying data do not support |
| DRAFT-COA-COMPLETE/006 | Draft synthesis: Completeness of certificates of analysis in the… | Dr Theodora Ingelbrecht | Baseline imbalance in a small contributing trial is not remarked on |
| DRAFT-COUNTERION-C/005 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Rukayat Zaleski-Mbeki | A superseded version should remain reachable from the version that replaced it |
| DRAFT-COUNTERION-C/011 | Draft synthesis: Counter-ion content and its effect on delivered… | Dr Jacinta Steenkamp-Ferreira | Baseline imbalance in a small contributing trial is not remarked on |
| DRAFT-RUSSIAN-REGI/008 | Draft synthesis: Nationally registered neuropeptides and the… | Dr Thaddeus Isaksen-Balogun | A sortable table implies a comparison the underlying data do not support |
| DRAFT-SPONSOR-COND/002 | Draft synthesis: The consequences of a wholly sponsor-generated… | Dr Yehudit Quaresma | A sortable table implies a comparison the underlying data do not support |
| DRAFT-SURROGATE-OU/001 | Draft synthesis: Percentage weight change as a surrogate outcome | Dr Amara Quaresma | Declared interests should appear on the document rather than on a separate page |
| DRAFT-AMYLIN-ANALO/008 | Draft synthesis: Amylin analogues as monotherapy and in combination | Dr Lorcan Whitmarsh-Obi | Declared interests should appear on the document rather than on a separate page |
| DRAFT-DISCONTINUED/002 | Draft synthesis: Discontinued development programmes as evidence | Dr Gervase Crickhowell | A sortable table implies a comparison the underlying data do not support |
| DRAFT-RECONSTITUTI/009 | Draft synthesis: Reconstitution practice and delivered dose | Dr Gaspard Wintringham | Declared interests should appear on the document rather than on a separate page |
| DRAFT-PANCREATITIS/001 | Draft synthesis: Acute pancreatitis with incretin-based therapies | Zdenka Ximenes | Baseline imbalance in a small contributing trial is not remarked on |
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