Consultation record
Submissions accepted — page 17
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 17 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-THYMOSIN-ALP/002 | Draft monograph: Thymosin alpha-1 | Dr Lorcan Zaleski-Mbeki | The search date is not on the face of the document |
| DRAFT-THYMOSIN-ALP/003 | Draft monograph: Thymosin alpha-1 | Dr Mordecai Bellingham-Ojo | The analytical section assumes a reference standard that is not generally available |
| DRAFT-THYMOSIN-ALP/008 | Draft monograph: Thymosin alpha-1 | Dr Yehudit Yorkstone | Doses are expressed in units that differ between sections |
| DRAFT-THYMOSIN-ALP/010 | Draft monograph: Thymosin alpha-1 | Dr Liesbeth Quenneville | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-THYMOSIN-ALP/001 | Draft monograph: Thymosin alpha-1 | Dr Katarzyna Yorkstone | Registered trials that never reported are absent from the monograph |
| DRAFT-THYMOSIN-BET/002 | Draft monograph: Thymosin beta-4 | Dr Mordecai Glendinning-Uche | What happens when the compound is stopped is not addressed |
| DRAFT-THYMOSIN-BET/013 | Draft monograph: Thymosin beta-4 | Dr Georgiana Zimmerthal | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-THYMOSIN-BET/004 | Draft monograph: Thymosin beta-4 | Dr Anselm Thorsby-Nakamura | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-THYMOSIN-BET/014 | Draft monograph: Thymosin beta-4 | Dr Beatrijs Hazelrigg | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-THYMOSIN-BET/003 | Draft monograph: Thymosin beta-4 | Dr Torvald Kettlewell | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-THYMOSIN-BET/005 | Draft monograph: Thymosin beta-4 | Dr Bertrand Steenkamp-Ferreira | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-THYMOSIN-BET/012 | Draft monograph: Thymosin beta-4 | Dr Gervase Abergavenny | Effect estimates are given without naming the comparator |
| DRAFT-THYMOSIN-BET/015 | Draft monograph: Thymosin beta-4 | Dr Yehudit Quaresma | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-THYMOSIN-BET/010 | Draft monograph: Thymosin beta-4 | Dr Kamila Ubertini | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-LCMSMS-IDENT/002 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Fenella Lavrentiev | The scope does not say which materials the standard excludes |
| DRAFT-LCMSMS-IDENT/001 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Ludmila Brackenridge | A determination does not record the version of the standard it was made under |
| DRAFT-LCMSMS-IDENT/005 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Valentin Castellanos-Reid | The standard would be applied more consistently with a worked example |
| DRAFT-LCMSMS-IDENT/003 | Draft standard CEI-MS-02: Confirmation of peptide identity by liquid… | Dr Wilhelmina Wintringham | The limitations section states what the method cannot do but not what a reader will wrongly conclude |
| DRAFT-PEPTIDE-CONT/005 | Draft standard CEI-MS-03: Determination of peptide content and its… | Hortensia Hollingworth | 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… | Dr Zdenka Nyquist-Obiora | The limitations section states what the method cannot do but not what a reader will wrongly conclude |
| DRAFT-PEPTIDE-CONT/003 | Draft standard CEI-MS-03: Determination of peptide content and its… | Professor Bartolomeu Nkosi-Lindegaard | The search date is not on the face of the document |
| DRAFT-PEPTIDE-CONT/004 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Hyacinth Drakeford-Amadi | A determination does not record the version of the standard it was made under |
| DRAFT-PEPTIDE-CONT/010 | Draft standard CEI-MS-03: Determination of peptide content and its… | Hortensia Beauchamp-Ekong | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-PEPTIDE-CONT/007 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Eulalia Sonnenberg-Eze | The reporting threshold is not tied to a demonstrated limit of quantitation |
| DRAFT-PEPTIDE-CONT/008 | Draft standard CEI-MS-03: Determination of peptide content and its… | Dr Liesbeth Nyquist-Obiora | The standard would be applied more consistently with a worked example |
| DRAFT-WATER-KARL-F/010 | Draft standard CEI-MS-04: Determination of water content in… | Dr Frideswide Grünbaum-Sowande | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-WATER-KARL-F/011 | Draft standard CEI-MS-04: Determination of water content in… | Dr Séverine Oduya-Kaltenbrunner | A determination does not record the version of the standard it was made under |
| DRAFT-WATER-KARL-F/014 | Draft standard CEI-MS-04: Determination of water content in… | Dr Hyacinth Oyelaran-Steen | The same concept is given three different names in one document |
| DRAFT-WATER-KARL-F/005 | Draft standard CEI-MS-04: Determination of water content in… | Dr Wojciech Kaltenbach-Mensah | The standard assumes a reference standard of known assigned content |
| DRAFT-WATER-KARL-F/006 | Draft standard CEI-MS-04: Determination of water content in… | Dr Wolfram Tollemache | The standard does not say what to do with a result outside the expected range |
page 17 of 23