Consultation record

Submissions accepted in part

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 1 of 13

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

Reference	Consultation	Respondent	Point raised
DRAFT-CERTAINTY-FR/003	Draft revision of the Institute’s certainty assessment framework…	Anselm Mountstephen	The database set omits sources relevant to the compounds in scope
DRAFT-CERTAINTY-FR/004	Draft revision of the Institute’s certainty assessment framework…	Dr Kolawole Isaksen-Balogun	Point estimates are given without an interval
DRAFT-CERTAINTY-FR/005	Draft revision of the Institute’s certainty assessment framework…	Professor Bartolomeu Nkosi-Lindegaard	Sponsor concentration should be a recorded characteristic of a body of evidence
DRAFT-CERTAINTY-FR/008	Draft revision of the Institute’s certainty assessment framework…	Dr Oisín Rautavaara	The framework does not say when a concern warrants one level and when it warrants two
DRAFT-CERTAINTY-FR/013	Draft revision of the Institute’s certainty assessment framework…	Ms Rhiannon Okoye-Vandergraaf	The document is unreadable without specialist training
DRAFT-CERTAINTY-FR/015	Draft revision of the Institute’s certainty assessment framework…	Dr Yaa Kettlewell	No information-size criterion is applied before an interval is judged
DRAFT-SUPPLIER-RUB/003	Draft supplier evaluation rubric	Dr Quentin Zimmerthal	Two anchors on the same criterion can both describe the same supplier
DRAFT-SUPPLIER-RUB/004	Draft supplier evaluation rubric	Dr Fitzwilliam Danquah-Öberg	Documentary practice is weighted equally with analytical evidence
DRAFT-SUPPLIER-RUB/007	Draft supplier evaluation rubric	Dr Yaa Kettlewell	Point estimates are given without an interval
DRAFT-SUPPLIER-RUB/009	Draft supplier evaluation rubric	Dr Oisín Rautavaara	Scores are reported to a precision the underlying judgements do not support
DRAFT-COA-MINIMUM-/001	Draft certificate-of-analysis minimum data standard	Dr Vasilisa Immelmann	Nothing prevents a chromatogram being reprocessed until it passes
DRAFT-COA-MINIMUM-/003	Draft certificate-of-analysis minimum data standard	Dr Wolfram Quintanilha industry	The additional determinations required would materially increase release testing cost
DRAFT-COA-MINIMUM-/010	Draft certificate-of-analysis minimum data standard	Rukayat Zaleski-Mbeki	Nothing requires a laboratory to demonstrate ongoing performance
DRAFT-COA-MINIMUM-/011	Draft certificate-of-analysis minimum data standard	Dr Melisande Thorsby-Nakamura	Nothing in the standard addresses transfer of the method between laboratories
DRAFT-COA-MINIMUM-/013	Draft certificate-of-analysis minimum data standard	Dr Fenella Steenkamp-Ferreira	A field classified as critical is not one a reading turns on
DRAFT-RP-HPLC-PURI/005	Draft standard: determination of chromatographic purity by…	Dr Abimbola Sotomayor-Ekwueme	Nothing addresses the container the material was held in
DRAFT-SEMAGLUTIDE-/008	Draft monograph: semaglutide, version 3	Quentin Whitmarsh-Obi	References should carry a persistent identifier for every cited source
DRAFT-SEMAGLUTIDE-/012	Draft monograph: semaglutide, version 3	Dr Henrike Jastrzębska	The analytical section is longer than the clinical assessment it accompanies
DRAFT-TIRZEPATIDE-/005	Draft monograph: tirzepatide, version 2	Dr Henrike Jastrzębska	The recorded evidence gaps omit outcomes a reader would consider material
DRAFT-TIRZEPATIDE-/006	Draft monograph: tirzepatide, version 2	Dr Katarzyna Yorkstone	Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome…
DRAFT-TIRZEPATIDE-/008	Draft monograph: tirzepatide, version 2	Ms Rhiannon Okoye-Vandergraaf	The document is unreadable without specialist training
DRAFT-TIRZEPATIDE-/013	Draft monograph: tirzepatide, version 2	Dr Liesbeth Zaleski-Mbeki	The analytical section is longer than the clinical assessment it accompanies
DRAFT-TIRZEPATIDE-/015	Draft monograph: tirzepatide, version 2	Dr Frideswide Nordhagen	The interaction section lists mechanisms rather than interactions
DRAFT-BPC-157-MONO/003	Draft monograph: BPC-157	Dr Fenella Steenkamp-Ferreira	The interaction section lists mechanisms rather than interactions
DRAFT-WEIGHT-REGAI/001	Draft synthesis: weight change after discontinuation of an incretin…	Ms Rhiannon Okoye-Vandergraaf	The document is unreadable without specialist training
DRAFT-WEIGHT-REGAI/003	Draft synthesis: weight change after discontinuation of an incretin…	Dr Vasilisa Immelmann	Regulatory assessment documents were not searched
DRAFT-WEIGHT-REGAI/004	Draft synthesis: weight change after discontinuation of an incretin…	Georgiana Zimmerthal	Studies not published in English were excluded without assessment
DRAFT-WEIGHT-REGAI/005	Draft synthesis: weight change after discontinuation of an incretin…	Dr Ndidi Ravensworth-Ilunga	The search was limited by publication date and the limit is not justified
DRAFT-WEIGHT-REGAI/006	Draft synthesis: weight change after discontinuation of an incretin…	Ivo Mountstephen	The review protocol is described but its registration record is not linked
DRAFT-WEIGHT-REGAI/010	Draft synthesis: weight change after discontinuation of an incretin…	Dr Adaeze Underhill-Okafor	Two included studies do not meet the registered eligibility criteria

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