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
377 documents · page 9 of 13
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-TESAMORELIN-/015 | Draft monograph: Tesamorelin | Dr Dmitri Nordhagen | The preclinical section is extensive and the clinical section is not |
| DRAFT-TESAMORELIN-/004 | Draft monograph: Tesamorelin | Dr Vasilisa Immelmann industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-THYMALIN-MON/005 | Draft monograph: Thymalin | Dr Amara Vandergraaf | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-THYMALIN-MON/004 | Draft monograph: Thymalin | Kolawole Jankowiak-Osei | The preclinical section is extensive and the clinical section is not |
| DRAFT-THYMALIN-MON/007 | Draft monograph: Thymalin | Professor Ekaterina Voskresenskaya-Hill industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-THYMALIN-MON/010 | Draft monograph: Thymalin | Dr Jolyon Grünbaum-Sowande | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-THYMALIN-MON/002 | Draft monograph: Thymalin | Dr Xenia Uttridge | The analytical section is longer than the clinical assessment it accompanies |
| DRAFT-THYMOSIN-ALP/006 | Draft monograph: Thymosin alpha-1 | Dr Sigrún Lavrentiev | Trials are described as terminated where they completed as planned |
| DRAFT-THYMOSIN-ALP/004 | Draft monograph: Thymosin alpha-1 | Dr Jacinta Steenkamp-Ferreira | References should carry a persistent identifier for every cited source |
| DRAFT-THYMOSIN-BET/011 | Draft monograph: Thymosin beta-4 | Hortensia Beauchamp-Ekong | The preclinical section is extensive and the clinical section is not |
| DRAFT-THYMOSIN-BET/006 | Draft monograph: Thymosin beta-4 | Dr Anselm Ashworth-Danquah | The recorded evidence gaps omit outcomes a reader would consider material |
| DRAFT-THYMOSIN-BET/009 | Draft monograph: Thymosin beta-4 | Dr Oswin Yorkstone | Where the compound is a glucagon-like peptide-1 receptor agonist, the cardiovascular outcome… |
| DRAFT-THYMOSIN-BET/007 | Draft monograph: Thymosin beta-4 | Dr Ivo Quintanilha | Storage and reconstitution guidance is given without stating what it rests on |
| DRAFT-THYMOSIN-BET/008 | Draft monograph: Thymosin beta-4 | Dr Katarzyna Oppenheimer-Ade industry | The monograph should reproduce the approved labelling rather than paraphrase it |
| DRAFT-LCMSMS-IDENT/006 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Frideswide Nordhagen | The document is unreadable without specialist training |
| DRAFT-LCMSMS-IDENT/004 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Matthias Whitmarsh-Obi | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-PEPTIDE-CONT/001 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Zofia Petrossian | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-WATER-KARL-F/016 | Draft standard CEI-MS-04: Determination of water content in… | Dr Leonhard Quenneville | References should carry a persistent identifier for every cited source |
| DRAFT-WATER-KARL-F/001 | Draft standard CEI-MS-04: Determination of water content in… | Ivo Mountstephen | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-WATER-KARL-F/007 | Draft standard CEI-MS-04: Determination of water content in… | Dr Abimbola Sotomayor-Ekwueme | The document is unreadable without specialist training |
| DRAFT-WATER-KARL-F/004 | Draft standard CEI-MS-04: Determination of water content in… | Dr Eamon Sandringham-Adu | Results are reported without an estimate of measurement uncertainty |
| DRAFT-WATER-KARL-F/002 | Draft standard CEI-MS-04: Determination of water content in… | Dr Wilhelmina Quaresma | A single determination is permitted where duplicates would be inexpensive |
| DRAFT-WATER-KARL-F/003 | Draft standard CEI-MS-04: Determination of water content in… | Dr Theodora Trelawney | A field classified as critical is not one a reading turns on |
| DRAFT-STERILITY-US/005 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Lorcan Uttridge industry | The additional determinations required would materially increase release testing cost |
| DRAFT-STERILITY-US/003 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Sigrún Vercingetorix | Nothing in the standard addresses transfer of the method between laboratories |
| DRAFT-STERILITY-US/013 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Ivo Mountstephen | Nothing requires a laboratory to demonstrate ongoing performance |
| DRAFT-STERILITY-US/010 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Sigrún Lavrentiev | Results are reported without an estimate of measurement uncertainty |
| DRAFT-STERILITY-US/009 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Radoslava Palmgren-Kofi | Point estimates are given without an interval |
| DRAFT-PARTICULATE-/011 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Zebedee Zaleski-Mbeki | A system suitability criterion is unachievable on instrumentation in general use |
| DRAFT-PARTICULATE-/005 | Draft standard CEI-MS-07: Sub-visible particulate matter in… | Dr Ottoline Oppenheimer-Ade | A single determination is permitted where duplicates would be inexpensive |
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