Consultation record
Submissions noted, no amendment — page 3
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
109 documents · page 3 of 4
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-KPV-MONOGRAP/010 | Draft monograph: KPV | Anselm Mountstephen | A superseded version should remain reachable from the version that replaced it |
| DRAFT-LARAZOTIDE-M/003 | Draft monograph: Larazotide acetate | Anselm Mountstephen | A superseded version should remain reachable from the version that replaced it |
| DRAFT-LL-37-MONOGR/001 | Draft monograph: LL-37 | Vittoria Ylönen | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-MAZDUTIDE-MO/005 | Draft monograph: Mazdutide | Dr Rurik Haverkamp-Diallo | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-NAD-PLUS-MON/001 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Xenia Nyquist-Obiora | Guidance on lyophilised storage is missing |
| DRAFT-ORAL-SEMAGLU/004 | Draft monograph: Semaglutide, oral | Dr Rurik Haverkamp-Diallo | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-PETRELINTIDE/015 | Draft monograph: Petrelintide | Georgiana Zimmerthal | Declared interests should appear on the document rather than on a separate page |
| DRAFT-PRAMLINTIDE-/002 | Draft monograph: Pramlintide | Dr Evander Ashworth-Danquah | A sortable table implies a comparison the underlying data do not support |
| DRAFT-PT-141-MONOG/013 | Draft monograph: PT-141 (bremelanotide) | Dr Quentin Gwynne-Sarpong | Declared interests should appear on the document rather than on a separate page |
| DRAFT-SELANK-MONOG/008 | Draft monograph: Selank | Georgiana Zimmerthal | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-SEMAX-MONOGR/004 | Draft monograph: Semax | Ivo Mountstephen | A superseded version should remain reachable from the version that replaced it |
| DRAFT-SERMORELIN-M/005 | Draft monograph: Sermorelin | Dr Rurik Haverkamp-Diallo | Declared interests should appear on the document rather than on a separate page |
| DRAFT-SERMORELIN-M/008 | Draft monograph: Sermorelin | Dr Liesbeth Nyquist-Obiora | Guidance on lyophilised storage is missing |
| DRAFT-SERMORELIN-M/009 | Draft monograph: Sermorelin | Dr Emiliana Ollerenshaw | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-SS-31-MONOGR/001 | Draft monograph: SS-31 (elamipretide) | Dr Liesbeth Nyquist-Obiora | Guidance on lyophilised storage is missing |
| DRAFT-SS-31-MONOGR/009 | Draft monograph: SS-31 (elamipretide) | Dr Constança Glendinning-Uche | A sortable table implies a comparison the underlying data do not support |
| DRAFT-TESAMORELIN-/004 | Draft monograph: Tesamorelin | Vittoria Ylönen | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-TESAMORELIN-/009 | Draft monograph: Tesamorelin | Dr Vasilisa Sandringham-Adu | Declared interests should appear on the document rather than on a separate page |
| DRAFT-THYMOSIN-BET/014 | Draft monograph: Thymosin beta-4 | Dr Abimbola Sotomayor-Ekwueme | Guidance on lyophilised storage is missing |
| DRAFT-THYMOSIN-BET/015 | Draft monograph: Thymosin beta-4 | Dr Quentin Gwynne-Sarpong | The monograph should not describe how the compound is supplied outside a regulated route |
| DRAFT-PEPTIDE-CONT/001 | Draft standard CEI-MS-03: Determination of peptide content and its… | Anselm Mountstephen | A superseded version should remain reachable from the version that replaced it |
| DRAFT-WATER-KARL-F/004 | Draft standard CEI-MS-04: Determination of water content in… | Dr Rurik Haverkamp-Diallo | Declared interests should appear on the document rather than on a separate page |
| DRAFT-WATER-KARL-F/006 | Draft standard CEI-MS-04: Determination of water content in… | Quentin Whitmarsh-Obi | A superseded version should remain reachable from the version that replaced it |
| DRAFT-STERILITY-US/011 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Eamon Sandringham-Adu | A superseded version should remain reachable from the version that replaced it |
| DRAFT-PARTICULATE-/002 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Professor Bartolomeu Nkosi-Lindegaard | The standard does not require retention of the primary data |
| DRAFT-COUNTER-ION-/016 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Wojciech Kaltenbach-Mensah | A sortable table implies a comparison the underlying data do not support |
| DRAFT-AGGREGATES-S/001 | Draft standard CEI-MS-11: Determination of aggregate content by… | Professor Bartolomeu Nkosi-Lindegaard | The standard does not require retention of the primary data |
| DRAFT-THIRD-PARTY-/005 | Draft standard CEI-MS-15: Protocol for independent third-party… | Dr Evander Ashworth-Danquah | A sortable table implies a comparison the underlying data do not support |
| DRAFT-APPEARANCE-S/001 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Dr Quentin Gwynne-Sarpong | Declared interests should appear on the document rather than on a separate page |
| DRAFT-APPEARANCE-S/010 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Stellan Cholmondeley-Ade | A superseded version should remain reachable from the version that replaced it |
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