Consultation record
Submissions not accepted — page 4
The submission is not accepted. The secretariat response gives the reason. A submission that is not accepted remains published in full; the Institute does not remove a submission because it disagrees with it.
Submissions
147 documents · page 4 of 5
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-SS-31-MONOGR/015 | Draft monograph: SS-31 (elamipretide) | Dr Rukayat Zaleski-Mbeki industry | The document should not describe uses outside the approved indication |
| DRAFT-SS-31-MONOGR/001 | Draft monograph: SS-31 (elamipretide) | Dr Theodora Trelawney | The document set should be published in translation |
| DRAFT-SURVODUTIDE-/004 | Draft monograph: Survodutide | Dr Liesbeth Achterberg | The monograph should state what the compound costs |
| DRAFT-SURVODUTIDE-/006 | Draft monograph: Survodutide | Dr Hyacinth Oyelaran-Steen | The document set should be published in translation |
| DRAFT-SURVODUTIDE-/014 | Draft monograph: Survodutide | Valentin Tollemache industry | The document should not describe uses outside the approved indication |
| DRAFT-TESAMORELIN-/005 | Draft monograph: Tesamorelin | Dr Bertrand Steenkamp-Ferreira | The document should state what a reader ought to do |
| DRAFT-TESAMORELIN-/012 | Draft monograph: Tesamorelin | Dr Georgiana Mountstephen industry | The document should not describe uses outside the approved indication |
| DRAFT-TESAMORELIN-/014 | Draft monograph: Tesamorelin | Rosalind Petrossian | The document set should be published in translation |
| DRAFT-THYMALIN-MON/009 | Draft monograph: Thymalin | Dr Ludmila Tollemache | The document should state what a reader ought to do |
| DRAFT-THYMOSIN-ALP/011 | Draft monograph: Thymosin alpha-1 | Ivo Mountstephen | The document set should be published in translation |
| DRAFT-THYMOSIN-ALP/012 | Draft monograph: Thymosin alpha-1 | Dr Wilhelmina Quaresma | The document should state what a reader ought to do |
| DRAFT-THYMOSIN-BET/001 | Draft monograph: Thymosin beta-4 | Dr Vittoria Ylönen | The document set should be published in translation |
| DRAFT-PEPTIDE-CONT/006 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Frideswide Hazelrigg | The standard should state a pass limit |
| DRAFT-PEPTIDE-CONT/011 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Vasilisa Immelmann | The document should state what a reader ought to do |
| DRAFT-STERILITY-US/001 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Ursina Ellsworth-Vance | The document should state what a reader ought to do |
| DRAFT-STERILITY-US/006 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Jacinta Grünbaum-Sowande | The document set should be published in translation |
| DRAFT-PARTICULATE-/001 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Theodora Ximenes | The standard should state a pass limit |
| DRAFT-PARTICULATE-/013 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Wolfram Kaltenbach-Mensah | The document set should be published in translation |
| DRAFT-RELATED-SUBS/001 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Quentin Enthoven | The document set should be published in translation |
| DRAFT-RELATED-SUBS/008 | Draft standard CEI-MS-08: Related-substances profiling and the… | Dr Séverine Oduya-Kaltenbrunner industry | The document should not describe uses outside the approved indication |
| DRAFT-COUNTER-ION-/001 | Draft standard CEI-MS-10: Identification and quantification of… | Dr Quentin Enthoven | The document set should be published in translation |
| DRAFT-AGGREGATES-S/006 | Draft standard CEI-MS-11: Determination of aggregate content by… | Dr Quintus Rautavaara | The document set should be published in translation |
| DRAFT-RESIDUAL-SOL/001 | Draft standard CEI-MS-12: Residual solvent determination by static… | Xenia Nyquist-Obiora | The standard should state a pass limit |
| DRAFT-RESIDUAL-SOL/009 | Draft standard CEI-MS-12: Residual solvent determination by static… | Dr Rukayat Zaleski-Mbeki | The standard should require documented operator competence |
| DRAFT-STABILITY-IN/003 | Draft standard CEI-MS-13: Development and validation of a… | Xenia Nyquist-Obiora | The document should state what a reader ought to do |
| DRAFT-STABILITY-IN/008 | Draft standard CEI-MS-13: Development and validation of a… | Leonhard Achterberg | The document set should be published in translation |
| DRAFT-STABILITY-IN/012 | Draft standard CEI-MS-13: Development and validation of a… | Dr Evander Whitmarsh-Obi | The standard should state a pass limit |
| DRAFT-STABILITY-IN/005 | Draft standard CEI-MS-13: Development and validation of a… | Dr Stellan Cholmondeley-Ade | The standard should require documented operator competence |
| DRAFT-STABILITY-IN/001 | Draft standard CEI-MS-13: Development and validation of a… | Vittoria Quintanilha industry | The document should not describe uses outside the approved indication |
| DRAFT-THIRD-PARTY-/010 | Draft standard CEI-MS-15: Protocol for independent third-party… | Dr Oisín Rautavaara | The standard should require documented operator competence |
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