Consultation record
Submissions accepted in part — page 11
Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.
Submissions
390 documents · page 11 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-THIRD-PARTY-/006 | Draft standard CEI-MS-15: Protocol for independent third-party… | Professor Bartolomeu Nkosi-Lindegaard | Nothing prevents a chromatogram being reprocessed until it passes |
| DRAFT-THIRD-PARTY-/008 | Draft standard CEI-MS-15: Protocol for independent third-party… | Dr Brigitta Grünbaum-Sowande | Acceptance criteria are expressed in terms specific to one instrument family |
| DRAFT-THIRD-PARTY-/012 | Draft standard CEI-MS-15: Protocol for independent third-party… | Dr Kolawole Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-APPEARANCE-S/003 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Dr Nikolai Yeovil-Bakare | A single method cannot support the conclusion the standard permits |
| DRAFT-APPEARANCE-S/005 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Dr Fenella Steenkamp-Ferreira | A field classified as critical is not one a reading turns on |
| DRAFT-APPEARANCE-S/007 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Dr Liesbeth Nyquist-Obiora | Nothing addresses the container the material was held in |
| DRAFT-APPEARANCE-S/012 | Draft standard CEI-MS-09: Assessment of appearance, cake integrity… | Dr Melisande Thorsby-Nakamura | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-POORLY-RETAI/003 | Draft standard CEI-MS-19: Purity determination for peptides not… | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes |
| DRAFT-POORLY-RETAI/010 | Draft standard CEI-MS-19: Purity determination for peptides not… | Dr Ottoline Fitzgerald-Nwosu | The preparation solvent is not specified and changes what is measured |
| DRAFT-POORLY-RETAI/011 | Draft standard CEI-MS-19: Purity determination for peptides not… | Dr Anselm Thorsby-Nakamura | Results are reported without an estimate of measurement uncertainty |
| DRAFT-POORLY-RETAI/012 | Draft standard CEI-MS-19: Purity determination for peptides not… | Dr Liesbeth Nyquist-Obiora | Nothing addresses the container the material was held in |
| DRAFT-PHOTOSTABILI/001 | Draft standard CEI-MS-20: Photostability assessment of… | Dr Fenella Steenkamp-Ferreira | A field classified as critical is not one a reading turns on |
| DRAFT-DUAL-VS-SING/001 | Draft synthesis: Dual and triple incretin receptor agonists compared… | Ms Rhiannon Okoye-Vandergraaf | Patient-reported outcomes are collected by the trials and not reported by the review |
| DRAFT-DUAL-VS-SING/005 | Draft synthesis: Dual and triple incretin receptor agonists compared… | Dr Quentin Enthoven | Studies not published in English were excluded without assessment |
| DRAFT-DUAL-VS-SING/006 | Draft synthesis: Dual and triple incretin receptor agonists compared… | Stellan Cholmondeley-Ade | References should carry a persistent identifier for every cited source |
| DRAFT-INCRETIN-CAR/001 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Vasilisa Immelmann | Regulatory assessment documents were not searched |
| DRAFT-INCRETIN-CAR/003 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Thaddeus Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-INCRETIN-CAR/004 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Georgiana Mountstephen | Studies not published in English were excluded without assessment |
| DRAFT-INCRETIN-CAR/006 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Wojciech Kaltenbach-Mensah | A surrogate outcome is used as the anchor without validation evidence |
| DRAFT-INCRETIN-CAR/012 | Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1… | Dr Yaa Kettlewell | Statistical heterogeneity is treated as though it measured clinical heterogeneity |
| DRAFT-GASTROINTEST/004 | Draft synthesis: Gastrointestinal adverse events with incretin… | Ivo Mountstephen | References should carry a persistent identifier for every cited source |
| DRAFT-GASTROINTEST/006 | Draft synthesis: Gastrointestinal adverse events with incretin… | Dr Vasilisa Immelmann | Regulatory assessment documents were not searched |
| DRAFT-GASTROINTEST/010 | Draft synthesis: Gastrointestinal adverse events with incretin… | Eamon Sandringham-Adu | The review protocol is described but its registration record is not linked |
| DRAFT-GASTROINTEST/012 | Draft synthesis: Gastrointestinal adverse events with incretin… | Dr Emiliana Ollerenshaw | Studies not published in English were excluded without assessment |
| DRAFT-ORAL-VS-INJE/001 | Draft synthesis: Oral compared with injectable presentations of… | Dr Yaa Kettlewell | Subgroup findings are reported that were not registered in the protocol |
| DRAFT-ORAL-VS-INJE/004 | Draft synthesis: Oral compared with injectable presentations of… | Dr Wojciech Kaltenbach-Mensah | A surrogate outcome is used as the anchor without validation evidence |
| DRAFT-ORAL-VS-INJE/005 | Draft synthesis: Oral compared with injectable presentations of… | Dr Vasilisa Sandringham-Adu | Studies not published in English were excluded without assessment |
| DRAFT-ORAL-VS-INJE/011 | Draft synthesis: Oral compared with injectable presentations of… | Thaddeus Isaksen-Balogun | Point estimates are given without an interval |
| DRAFT-ORAL-VS-INJE/012 | Draft synthesis: Oral compared with injectable presentations of… | Dr Odalys Thorsby-Nakamura | The same concern is used to downgrade in two domains |
| DRAFT-RENAL-OUTCOM/001 | Draft synthesis: Kidney outcomes with incretin receptor agonists in… | Thaddeus Isaksen-Balogun | Crossover trials are pooled with parallel-group trials without adjustment |
page 11 of 13