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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 in part — page 10

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

377 documents · page 10 of 13

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

ReferenceConsultationRespondentPoint raised
DRAFT-PARTICULATE-/012Draft standard CEI-MS-07: Sub-visible particulate matter in…Dr Ottoline Fitzgerald-NwosuA field classified as critical is not one a reading turns on
DRAFT-RELATED-SUBS/006Draft standard CEI-MS-08: Related-substances profiling and the…Dr Amara VandergraafAcceptance criteria are expressed in terms specific to one instrument family
DRAFT-RELATED-SUBS/009Draft standard CEI-MS-08: Related-substances profiling and the…Dr Xenia Uttridge industryThe additional determinations required would materially increase release testing cost
DRAFT-COUNTER-ION-/010Draft standard CEI-MS-10: Identification and quantification of…Dr Stellan Cholmondeley-Ade industryThe additional determinations required would materially increase release testing cost
DRAFT-COUNTER-ION-/008Draft standard CEI-MS-10: Identification and quantification of…Dr Séverine Oduya-KaltenbrunnerA single determination is permitted where duplicates would be inexpensive
DRAFT-COUNTER-ION-/006Draft standard CEI-MS-10: Identification and quantification of…Dr Amara VandergraafResults are reported without an estimate of measurement uncertainty
DRAFT-COUNTER-ION-/003Draft standard CEI-MS-10: Identification and quantification of…Dr Leonhard QuennevilleReferences should carry a persistent identifier for every cited source
DRAFT-COUNTER-ION-/009Draft standard CEI-MS-10: Identification and quantification of…Xiomara Fairweather-DuruA single method cannot support the conclusion the standard permits
DRAFT-COUNTER-ION-/012Draft standard CEI-MS-10: Identification and quantification of…Dr Theodora TrelawneyThe document is unreadable without specialist training
DRAFT-AGGREGATES-S/012Draft standard CEI-MS-11: Determination of aggregate content by…Dr Rosalind Grünbaum-SowandeNothing in the standard addresses transfer of the method between laboratories
DRAFT-AGGREGATES-S/003Draft standard CEI-MS-11: Determination of aggregate content by…Dr Oisín Marchetti-BasseyA single determination is permitted where duplicates would be inexpensive
DRAFT-AGGREGATES-S/008Draft standard CEI-MS-11: Determination of aggregate content by…Dr Wilhelmina ErlingssonReferences should carry a persistent identifier for every cited source
DRAFT-AGGREGATES-S/009Draft standard CEI-MS-11: Determination of aggregate content by…Dr Ndidi Ravensworth-IlungaPoint estimates are given without an interval
DRAFT-AGGREGATES-S/010Draft standard CEI-MS-11: Determination of aggregate content by…Leonhard AchterbergAcceptance criteria are expressed in terms specific to one instrument family
DRAFT-RESIDUAL-SOL/004Draft standard CEI-MS-12: Residual solvent determination by static…Dr Rurik Haverkamp-DialloA single method cannot support the conclusion the standard permits
DRAFT-RESIDUAL-SOL/014Draft standard CEI-MS-12: Residual solvent determination by static…Dr Yaa KettlewellA field classified as critical is not one a reading turns on
DRAFT-RESIDUAL-SOL/002Draft standard CEI-MS-12: Residual solvent determination by static…Dr Rurik Underhill-OkaforReferences should carry a persistent identifier for every cited source
DRAFT-RESIDUAL-SOL/012Draft standard CEI-MS-12: Residual solvent determination by static…Dr Quentin ZimmerthalResults are reported without an estimate of measurement uncertainty
DRAFT-RESIDUAL-SOL/006Draft standard CEI-MS-12: Residual solvent determination by static…Ignatius ErlingssonNothing requires a laboratory to demonstrate ongoing performance
DRAFT-STABILITY-IN/011Draft standard CEI-MS-13: Development and validation of a…Dr Nikolai Yeovil-BakareReferences should carry a persistent identifier for every cited source
DRAFT-STABILITY-IN/010Draft standard CEI-MS-13: Development and validation of a…Dr Wilhelmina ErlingssonNothing requires a laboratory to demonstrate ongoing performance
DRAFT-STABILITY-IN/013Draft standard CEI-MS-13: Development and validation of a…Dr Jozef Brandvold-AchterbergThe document is unreadable without specialist training
DRAFT-THIRD-PARTY-/011Draft standard CEI-MS-15: Protocol for independent third-party…Dr Jerome Lavrentiev industryThe additional determinations required would materially increase release testing cost
DRAFT-THIRD-PARTY-/006Draft standard CEI-MS-15: Protocol for independent third-party…Hortensia Beauchamp-EkongA single determination is permitted where duplicates would be inexpensive
DRAFT-APPEARANCE-S/008Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Hortensia Beauchamp-Ekong industryThe additional determinations required would materially increase release testing cost
DRAFT-APPEARANCE-S/007Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Gervase AbergavennyThe document is unreadable without specialist training
DRAFT-APPEARANCE-S/004Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Frideswide HazelriggPoint estimates are given without an interval
DRAFT-APPEARANCE-S/001Draft standard CEI-MS-09: Assessment of appearance, cake integrity…Dr Melisande Kirkpatrick-OlaNothing requires a laboratory to demonstrate ongoing performance
DRAFT-POORLY-RETAI/013Draft standard CEI-MS-19: Purity determination for peptides not…Dr Xenia UttridgeReferences should carry a persistent identifier for every cited source
DRAFT-POORLY-RETAI/010Draft standard CEI-MS-19: Purity determination for peptides not…Dr Matthias Whitmarsh-ObiThe document is unreadable without specialist training

page 10 of 13

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