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
735 documents · page 17 of 25
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-PT-141-MONOG/017 | Draft monograph: PT-141 (bremelanotide) | Ivo Mountstephen | The compound is supplied under names the monograph does not list |
| DRAFT-SELANK-MONOG/002 | Draft monograph: Selank | Dr Xenia Nyquist-Obiora | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-SELANK-MONOG/005 | Draft monograph: Selank | Dr Sigrún Vercingetorix | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-SELANK-MONOG/007 | Draft monograph: Selank | Dr Melisande Thorsby-Nakamura | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-SEMAX-MONOGR/001 | Draft monograph: Semax | Dr Vittoria Quintanilha | Open-label extension data are presented alongside randomised data without distinction |
| DRAFT-SEMAX-MONOGR/002 | Draft monograph: Semax | Dr Abimbola Sotomayor-Ekwueme | The route of administration studied is not the route in which the compound is supplied |
| DRAFT-SEMAX-MONOGR/003 | Draft monograph: Semax | Dr Zdenka Nyquist-Obiora | Evidence for one member of the class is presented as evidence for this compound |
| DRAFT-SEMAX-MONOGR/006 | Draft monograph: Semax | Dr Yusuf Whitmarsh-Obi | Effect estimates are given without naming the comparator |
| DRAFT-SEMAX-MONOGR/007 | Draft monograph: Semax | Anselm Mountstephen | The compound is supplied under names the monograph does not list |
| DRAFT-SEMAX-MONOGR/008 | Draft monograph: Semax | Dr Adaeze Underhill-Okafor | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-SEMAX-MONOGR/009 | Draft monograph: Semax | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-SEMAX-MONOGR/010 | Draft monograph: Semax | Dr Ottoline Fitzgerald-Nwosu | Preclinical findings are reported without the model that produced them |
| DRAFT-SEMAX-MONOGR/011 | Draft monograph: Semax | Vittoria Ylönen | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-SEMAX-MONOGR/012 | Draft monograph: Semax | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SEMAX-MONOGR/015 | Draft monograph: Semax | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document |
| DRAFT-SERMORELIN-M/001 | Draft monograph: Sermorelin | Dr Zdenka Ximenes | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-SERMORELIN-M/003 | Draft monograph: Sermorelin | Dr Hortensia Larsson-Ekwueme | Local reactions are omitted from the adverse-event table because the trials reported them separately |
| DRAFT-SERMORELIN-M/004 | Draft monograph: Sermorelin | Quentin Whitmarsh-Obi | The compound is supplied under names the monograph does not list |
| DRAFT-SERMORELIN-M/006 | Draft monograph: Sermorelin | Dr Vasilisa Immelmann | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SERMORELIN-M/007 | Draft monograph: Sermorelin | Dr Oswin Yorkstone | The supply section does not record that endotoxin is not determined |
| DRAFT-SS-31-MONOGR/004 | Draft monograph: SS-31 (elamipretide) | Dr Eamon Immelmann | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-SS-31-MONOGR/005 | Draft monograph: SS-31 (elamipretide) | Dr Brigitta Grünbaum-Sowande | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-SS-31-MONOGR/006 | Draft monograph: SS-31 (elamipretide) | Dr Ndidi Ravensworth-Ilunga | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-SS-31-MONOGR/007 | Draft monograph: SS-31 (elamipretide) | Stellan Cholmondeley-Ade | The compound is supplied under names the monograph does not list |
| DRAFT-SS-31-MONOGR/008 | Draft monograph: SS-31 (elamipretide) | Dr Zdenka Nyquist-Obiora | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-SS-31-MONOGR/010 | Draft monograph: SS-31 (elamipretide) | Dr Evander Whitmarsh-Obi | The monograph does not tell a reader that two vials of the same compound may not contain the same… |
| DRAFT-SS-31-MONOGR/011 | Draft monograph: SS-31 (elamipretide) | Dr Wolfram Quintanilha industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-SS-31-MONOGR/012 | Draft monograph: SS-31 (elamipretide) | Dr Evander Ashworth-Danquah | The same concept is given three different names in one document |
| DRAFT-SS-31-MONOGR/013 | Draft monograph: SS-31 (elamipretide) | Dr Rurik Underhill-Okafor | Nothing is said about impaired renal or hepatic clearance |
| DRAFT-SURVODUTIDE-/002 | Draft monograph: Survodutide | Dr Yehudit Yorkstone | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
page 17 of 25