Consultation record

Submissions accepted — page 20

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 20 of 23

Table 1. Submissions with this disposition, on this page.

Reference	Consultation	Respondent	Point raised
DRAFT-POORLY-RETAI/011	Draft standard CEI-MS-19: Purity determination for peptides not…	Kolawole Jankowiak-Osei	The standard would be applied more consistently with a worked example
DRAFT-POORLY-RETAI/012	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Ngozi Zetterlund	The standard does not say what to do with a result outside the expected range
DRAFT-POORLY-RETAI/009	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Wilhelmina Wintringham	The draft prescribes a procedure where it should state performance
DRAFT-POORLY-RETAI/007	Draft standard CEI-MS-19: Purity determination for peptides not…	Ludmila Brackenridge	Absence of evidence is presented in a form a reader will take as negative evidence
DRAFT-POORLY-RETAI/008	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Fenella Lavrentiev	The matrix interferes with the determination and no control is required
DRAFT-POORLY-RETAI/006	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Hamish Nyquist-Obiora	Rounding conventions are not stated and change the reported result
DRAFT-POORLY-RETAI/016	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Jolanta Uttridge	A determination does not record the version of the standard it was made under
DRAFT-POORLY-RETAI/015	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Georgiana Mountstephen	The search date is not on the face of the document
DRAFT-POORLY-RETAI/004	Draft standard CEI-MS-19: Purity determination for peptides not…	Dr Frideswide Nordhagen	The same concept is given three different names in one document
DRAFT-PHOTOSTABILI/004	Draft standard CEI-MS-20: Photostability assessment of…	Dr Katarzyna Yorkstone	A determination does not record the version of the standard it was made under
DRAFT-PHOTOSTABILI/003	Draft standard CEI-MS-20: Photostability assessment of…	Dr Lorcan Zaleski-Mbeki	The scope does not say which materials the standard excludes
DRAFT-DUAL-VS-SING/004	Draft synthesis: Dual and triple incretin receptor agonists compared…	Ludmila Brackenridge	Absence of evidence is presented in a form a reader will take as negative evidence
DRAFT-DUAL-VS-SING/003	Draft synthesis: Dual and triple incretin receptor agonists compared…	Dr Fenella Lavrentiev	The same concept is given three different names in one document
DRAFT-DUAL-VS-SING/005	Draft synthesis: Dual and triple incretin receptor agonists compared…	Dr Hamish Nyquist-Obiora	Doses differing several-fold are pooled without examining dose-response
DRAFT-DUAL-VS-SING/002	Draft synthesis: Dual and triple incretin receptor agonists compared…	Dr Wilhelmina Wintringham	Efficacy outcomes are rated for certainty and harms are not
DRAFT-DUAL-VS-SING/001	Draft synthesis: Dual and triple incretin receptor agonists compared…	Dr Matthias Whitmarsh-Obi	The review does not say when it will be updated or what would trigger an update
DRAFT-INCRETIN-CAR/009	Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1…	Dr Georgiana Mountstephen	The conclusion is stated more strongly than the certainty rating supports
DRAFT-INCRETIN-CAR/003	Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1…	Dr Amara Quaresma	Studies using different outcome definitions are pooled into one estimate
DRAFT-INCRETIN-CAR/008	Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1…	Dr Mordecai Bellingham-Ojo	A single-trial result is presented in the visual form of a pooled estimate
DRAFT-INCRETIN-CAR/001	Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1…	Dr Wolfram Kaltenbach-Mensah	A funnel plot is presented for a set too small to interpret it
DRAFT-INCRETIN-CAR/013	Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1…	Dr Henrike Jastrzębska	Intention-to-treat and efficacy-estimand results are combined without distinction
DRAFT-INCRETIN-CAR/006	Draft synthesis: Cardiovascular outcomes with glucagon-like peptide-1…	Dr Katarzyna Yorkstone	Efficacy outcomes are rated for certainty and harms are not
DRAFT-GASTROINTEST/005	Draft synthesis: Gastrointestinal adverse events with incretin…	Dr Rurik Underhill-Okafor industry	Two factual descriptions of the sponsor's programme are inaccurate
DRAFT-GASTROINTEST/009	Draft synthesis: Gastrointestinal adverse events with incretin…	Dr Eamon Immelmann	The same concept is given three different names in one document
DRAFT-GASTROINTEST/007	Draft synthesis: Gastrointestinal adverse events with incretin…	Dr Rurik Haverkamp-Diallo	The search strategy as published cannot be re-run
DRAFT-GASTROINTEST/001	Draft synthesis: Gastrointestinal adverse events with incretin…	Ignatius Erlingsson	The search date is not on the face of the document
DRAFT-GASTROINTEST/010	Draft synthesis: Gastrointestinal adverse events with incretin…	Dr Liesbeth Zaleski-Mbeki	Risk-of-bias judgements are reported as an overall rating without the domains
DRAFT-GASTROINTEST/011	Draft synthesis: Gastrointestinal adverse events with incretin…	Dr Liesbeth Zaleski-Mbeki	Efficacy outcomes are rated for certainty and harms are not
DRAFT-ORAL-VS-INJE/011	Draft synthesis: Oral compared with injectable presentations of…	Dr Bertrand Steenkamp-Ferreira	Analytical surveys are treated as evidence about suppliers when they establish only what was in a…
DRAFT-ORAL-VS-INJE/003	Draft synthesis: Oral compared with injectable presentations of…	Yusuf Whitmarsh-Obi industry	Two factual descriptions of the sponsor's programme are inaccurate

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