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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Consultation record

Submissions accepted — page 18

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 18 of 23

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

ReferenceConsultationRespondentPoint raised
DRAFT-WATER-KARL-F/012Draft standard CEI-MS-04: Determination of water content in…Dr Liesbeth AchterbergThe search date is not on the face of the document
DRAFT-WATER-KARL-F/009Draft standard CEI-MS-04: Determination of water content in…Dr Delphine RavensworthThe matrix interferes with the determination and no control is required
DRAFT-WATER-KARL-F/015Draft standard CEI-MS-04: Determination of water content in…Dr Ilona Mbatha-FredriksenThe standard would be applied more consistently with a worked example
DRAFT-WATER-KARL-F/013Draft standard CEI-MS-04: Determination of water content in…Dr Amara VandergraafThe limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-WATER-KARL-F/008Draft standard CEI-MS-04: Determination of water content in…Dr Ulysses Bellingham-OjoA conformance claim is not defined and will be made loosely
DRAFT-STERILITY-US/002Draft standard CEI-MS-06: Sterility testing of peptide preparations…Dr Piotr HollingworthThe search date is not on the face of the document
DRAFT-STERILITY-US/004Draft standard CEI-MS-06: Sterility testing of peptide preparations…Dr Odalys Thorsby-NakamuraThe matrix interferes with the determination and no control is required
DRAFT-STERILITY-US/008Draft standard CEI-MS-06: Sterility testing of peptide preparations…Dr Gaspard WintringhamThe standard assumes a reference standard of known assigned content
DRAFT-STERILITY-US/011Draft standard CEI-MS-06: Sterility testing of peptide preparations…Dr Theodora TrelawneyTerms are used in senses that differ from established pharmacopoeial usage
DRAFT-STERILITY-US/012Draft standard CEI-MS-06: Sterility testing of peptide preparations…Dr Eamon Sandringham-AduThe scope does not say which materials the standard excludes
DRAFT-STERILITY-US/007Draft standard CEI-MS-06: Sterility testing of peptide preparations…Dr Oisín Rautavaara industryTwo factual descriptions of the sponsor's programme are inaccurate
DRAFT-PARTICULATE-/002Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Jerome PetrossianThe standard does not state that a determination on one unit says nothing about the batch
DRAFT-PARTICULATE-/007Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Quentin Whitmarsh-ObiA determination does not record the version of the standard it was made under
DRAFT-PARTICULATE-/008Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Delphine TrelawneyThe search date is not on the face of the document
DRAFT-PARTICULATE-/009Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Kamila UbertiniThe standard does not say what to do with a result outside the expected range
DRAFT-PARTICULATE-/004Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Quintus KettlewellThe reporting threshold is not tied to a demonstrated limit of quantitation
DRAFT-PARTICULATE-/006Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Hortensia Larsson-EkwuemeTerms are used in senses that differ from established pharmacopoeial usage
DRAFT-PARTICULATE-/010Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Oswin YorkstoneThe standard assumes a reference standard of known assigned content
DRAFT-PARTICULATE-/003Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Theodora IngelbrechtA conformance claim is not defined and will be made loosely
DRAFT-RELATED-SUBS/003Draft standard CEI-MS-08: Related-substances profiling and the…Dr Leonhard QuennevilleThe same concept is given three different names in one document
DRAFT-RELATED-SUBS/005Draft standard CEI-MS-08: Related-substances profiling and the…Dr Hyacinth Oyelaran-SteenQuantitative claims are reproduced without the method that produced them
DRAFT-RELATED-SUBS/002Draft standard CEI-MS-08: Related-substances profiling and the…Dr Emiliana OllerenshawThe draft prescribes a procedure where it should state performance
DRAFT-COUNTER-ION-/004Draft standard CEI-MS-10: Identification and quantification of…Dr Ilona Mbatha-Fredriksen industryTwo factual descriptions of the sponsor's programme are inaccurate
DRAFT-COUNTER-ION-/014Draft standard CEI-MS-10: Identification and quantification of…Ivo MountstephenThe same concept is given three different names in one document
DRAFT-COUNTER-ION-/002Draft standard CEI-MS-10: Identification and quantification of…Dr Emiliana OllerenshawA conformance claim is not defined and will be made loosely
DRAFT-COUNTER-ION-/007Draft standard CEI-MS-10: Identification and quantification of…Dr Liesbeth AchterbergTerms are used in senses that differ from established pharmacopoeial usage
DRAFT-COUNTER-ION-/015Draft standard CEI-MS-10: Identification and quantification of…Dr Ulysses Bellingham-OjoThe limitations section states what the method cannot do but not what a reader will wrongly conclude
DRAFT-COUNTER-ION-/016Draft standard CEI-MS-10: Identification and quantification of…Dr Abimbola Sotomayor-EkwuemeThe search date is not on the face of the document
DRAFT-COUNTER-ION-/005Draft standard CEI-MS-10: Identification and quantification of…Dr Hyacinth Oyelaran-SteenThe scope does not say which materials the standard excludes
DRAFT-COUNTER-ION-/011Draft standard CEI-MS-10: Identification and quantification of…Dr Eamon Sandringham-AduThe standard does not say what to do with a result outside the expected range

page 18 of 23

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