Consultation record
Submissions accepted — page 19
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
735 documents · page 19 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-THYMALIN-MON/009 | Draft monograph: Thymalin | Dr Jolanta Uttridge | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-THYMALIN-MON/010 | Draft monograph: Thymalin | Dr Eulalia Sonnenberg-Eze | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-THYMOSIN-ALP/002 | Draft monograph: Thymosin alpha-1 | Dr Frideswide Hazelrigg | The absence of paediatric evidence is not stated where a reader would look for it |
| DRAFT-THYMOSIN-ALP/004 | Draft monograph: Thymosin alpha-1 | Dr Rurik Underhill-Okafor | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-THYMOSIN-ALP/005 | Draft monograph: Thymosin alpha-1 | Dr Odalys Thorsby-Nakamura | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-THYMOSIN-ALP/010 | Draft monograph: Thymosin alpha-1 | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-THYMOSIN-ALP/011 | Draft monograph: Thymosin alpha-1 | Dr Adaeze Underhill-Okafor | Effect estimates are given without naming the comparator |
| DRAFT-THYMOSIN-ALP/013 | Draft monograph: Thymosin alpha-1 | Dr Vittoria Quintanilha | Registered trials that never reported are absent from the monograph |
| DRAFT-THYMOSIN-BET/001 | Draft monograph: Thymosin beta-4 | Dr Melisande Kirkpatrick-Ola | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-THYMOSIN-BET/002 | Draft monograph: Thymosin beta-4 | Dr Rosalind Petrossian | Doses are expressed in units that differ between sections |
| DRAFT-THYMOSIN-BET/003 | Draft monograph: Thymosin beta-4 | Dr Marisol Dunmore-Ekpo | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-THYMOSIN-BET/004 | Draft monograph: Thymosin beta-4 | Dr Yusuf Whitmarsh-Obi | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-THYMOSIN-BET/005 | Draft monograph: Thymosin beta-4 | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-THYMOSIN-BET/009 | Draft monograph: Thymosin beta-4 | Dr Kamila Glendinning-Uche | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-THYMOSIN-BET/010 | Draft monograph: Thymosin beta-4 | Wilhelmina Quaresma | The supply section does not record that endotoxin is not determined |
| DRAFT-THYMOSIN-BET/011 | Draft monograph: Thymosin beta-4 | Dr Wolfram Quintanilha industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-THYMOSIN-BET/012 | Draft monograph: Thymosin beta-4 | Dr Piotr Hollingworth | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-THYMOSIN-BET/013 | Draft monograph: Thymosin beta-4 | Dr Radoslava Palmgren-Kofi | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-LCMSMS-IDENT/001 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Anselm Mountstephen | A determination does not record the version of the standard it was made under |
| DRAFT-LCMSMS-IDENT/003 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Abimbola Sotomayor-Ekwueme | The standard does not state that a determination on one unit says nothing about the batch |
| DRAFT-PEPTIDE-CONT/002 | Draft standard CEI-MS-03: Determination of peptide content and its… | Ivo Mountstephen | A determination does not record the version of the standard it was made under |
| DRAFT-PEPTIDE-CONT/003 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Hortensia Hollingworth | The standard permits a purity figure to be described as an assay |
| DRAFT-PEPTIDE-CONT/007 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Zebedee Zaleski-Mbeki | The limitations section states what the method cannot do but not what a reader will wrongly conclude |
| DRAFT-PEPTIDE-CONT/010 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Quentin Zimmerthal | The draft prescribes a procedure where it should state performance |
| DRAFT-PEPTIDE-CONT/011 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Liesbeth Nyquist-Obiora | The standard does not state that a determination on one unit says nothing about the batch |
| DRAFT-WATER-KARL-F/008 | Draft standard CEI-MS-04: Determination of water content in… | Dr Kamila Glendinning-Uche | The standard assumes a reference standard of known assigned content |
| DRAFT-WATER-KARL-F/009 | Draft standard CEI-MS-04: Determination of water content in… | Dr Fitzwilliam Danquah-Öberg | The draft prescribes a procedure where it should state performance |
| DRAFT-WATER-KARL-F/011 | Draft standard CEI-MS-04: Determination of water content in… | Dr Quentin Zimmerthal | Nothing states how long a prepared standard solution remains usable |
| DRAFT-WATER-KARL-F/012 | Draft standard CEI-MS-04: Determination of water content in… | Dr Eamon Immelmann | Quantitative claims are reproduced without the method that produced them |
| DRAFT-STERILITY-US/003 | Draft standard CEI-MS-06: Sterility testing of peptide preparations… | Dr Frideswide Nordhagen | The standard would be applied more consistently with a worked example |
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