Consultation record
Submissions accepted in part — page 9
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 9 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-THYMALIN-MON/008 | Draft monograph: Thymalin | Ms Rhiannon Okoye-Vandergraaf | The document is unreadable without specialist training |
| DRAFT-THYMOSIN-ALP/001 | Draft monograph: Thymosin alpha-1 | Dr Ivo Quintanilha | Trials are described as terminated where they completed as planned |
| DRAFT-THYMOSIN-ALP/006 | Draft monograph: Thymosin alpha-1 | Anselm Mountstephen | References should carry a persistent identifier for every cited source |
| DRAFT-THYMOSIN-ALP/008 | Draft monograph: Thymosin alpha-1 | Dr Zdenka Nyquist-Obiora | The preclinical section is extensive and the clinical section is not |
| DRAFT-THYMOSIN-ALP/009 | Draft monograph: Thymosin alpha-1 | Dr Hyacinth Drakeford-Amadi | The interaction section lists mechanisms rather than interactions |
| DRAFT-THYMOSIN-ALP/012 | Draft monograph: Thymosin alpha-1 | Dr Henrike Jastrzębska | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-THYMOSIN-BET/006 | Draft monograph: Thymosin beta-4 | Dr Theodora Ingelbrecht | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-THYMOSIN-BET/007 | Draft monograph: Thymosin beta-4 | Dr Perpetua Haverkamp-Diallo industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-THYMOSIN-BET/008 | Draft monograph: Thymosin beta-4 | Quentin Whitmarsh-Obi | References should carry a persistent identifier for every cited source |
| DRAFT-LCMSMS-IDENT/002 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Zebedee Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-LCMSMS-IDENT/004 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Quentin Zimmerthal | Results are reported without an estimate of measurement uncertainty |
| DRAFT-LCMSMS-IDENT/006 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Liesbeth Nyquist-Obiora | Nothing addresses the container the material was held in |
| DRAFT-PEPTIDE-CONT/004 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Fitzwilliam Danquah-Öberg | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-PEPTIDE-CONT/005 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Gervase Abergavenny | The preparation solvent is not specified and changes what is measured |
| DRAFT-PEPTIDE-CONT/006 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Séverine Oduya-Kaltenbrunner | A single method cannot support the conclusion the standard permits |
| DRAFT-PEPTIDE-CONT/009 | Draft standard CEI-MS-03: Determination of peptide content and its… | Thaddeus Isaksen-Balogun | A single determination is permitted where duplicates would be inexpensive |
| DRAFT-WATER-KARL-F/001 | Draft standard CEI-MS-04: Determination of water content in… | Dr Melisande Thorsby-Nakamura | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-WATER-KARL-F/002 | Draft standard CEI-MS-04: Determination of water content in… | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes |
| DRAFT-WATER-KARL-F/005 | Draft standard CEI-MS-04: Determination of water content in… | Rukayat Zaleski-Mbeki | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-WATER-KARL-F/007 | Draft standard CEI-MS-04: Determination of water content in… | Dr Sigrún Vercingetorix | Acceptance criteria are expressed in terms specific to one instrument family |
| DRAFT-WATER-KARL-F/010 | Draft standard CEI-MS-04: Determination of water content in… | Dr Evander Whitmarsh-Obi | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-WATER-KARL-F/013 | Draft standard CEI-MS-04: Determination of water content in… | Dr Anselm Thorsby-Nakamura | Results are reported without an estimate of measurement uncertainty |
| DRAFT-WATER-KARL-F/015 | Draft standard CEI-MS-04: Determination of water content in… | Dr Brigitta Grünbaum-Sowande | A single method cannot support the conclusion the standard permits |
| DRAFT-WATER-KARL-F/016 | Draft standard CEI-MS-04: Determination of water content in… | Dr Yehudit Yorkstone | The preparation solvent is not specified and changes what is measured |
| DRAFT-STERILITY-US/002 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Yaa Kettlewell | Point estimates are given without an interval |
| DRAFT-STERILITY-US/004 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Anselm Thorsby-Nakamura | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-STERILITY-US/005 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Fitzwilliam Danquah-Öberg | Results are reported without an estimate of measurement uncertainty |
| DRAFT-STERILITY-US/006 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Vasilisa Immelmann | Nothing prevents a chromatogram being reprocessed until it passes |
| DRAFT-STERILITY-US/010 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Theodora Trelawney | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-STERILITY-US/013 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Hyacinth Drakeford-Amadi | A field classified as critical is not one a reading turns on |
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