Consultation record
Submissions accepted — page 15
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 15 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-PT-141-MONOG/014 | Draft monograph: PT-141 (bremelanotide) | Dr Jolyon Grünbaum-Sowande | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-PT-141-MONOG/003 | Draft monograph: PT-141 (bremelanotide) | Dr Leonhard Quenneville | Quantitative claims are reproduced without the method that produced them |
| DRAFT-PT-141-MONOG/013 | Draft monograph: PT-141 (bremelanotide) | Dr Ludmila Tollemache | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-PT-141-MONOG/017 | Draft monograph: PT-141 (bremelanotide) | Dr Rukayat Zaleski-Mbeki | The compound is supplied under names the monograph does not list |
| DRAFT-PT-141-MONOG/015 | Draft monograph: PT-141 (bremelanotide) | Dr Ngozi Zetterlund | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-SELANK-MONOG/005 | Draft monograph: Selank | Radoslava Palmgren-Kofi | Quantitative claims are reproduced without the method that produced them |
| DRAFT-SELANK-MONOG/004 | Draft monograph: Selank | Dr Jacinta Steenkamp-Ferreira | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-SELANK-MONOG/007 | Draft monograph: Selank | Dr Melisande Thorsby-Nakamura industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-SELANK-MONOG/001 | Draft monograph: Selank | Dr Katarzyna Yorkstone | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SEMAX-MONOGR/005 | Draft monograph: Semax | Sigrún Vercingetorix | Adverse event frequencies are given without the denominator or the exposure period |
| DRAFT-SEMAX-MONOGR/007 | Draft monograph: Semax | Dr Anselm Mountstephen industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-SEMAX-MONOGR/013 | Draft monograph: Semax | Dr Ivo Quintanilha | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
| DRAFT-SEMAX-MONOGR/004 | Draft monograph: Semax | Dr Beatrijs Hazelrigg | Effect estimates are given without naming the comparator |
| DRAFT-SEMAX-MONOGR/001 | Draft monograph: Semax | Dr Yehudit Quaresma | What happens when the compound is stopped is not addressed |
| DRAFT-SEMAX-MONOGR/003 | Draft monograph: Semax | Dr Georgiana Zimmerthal | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-SEMAX-MONOGR/015 | Draft monograph: Semax | Dr Vittoria Ylönen | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-SEMAX-MONOGR/002 | Draft monograph: Semax | Dr Yolanda Norrington-Bhatt | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-SEMAX-MONOGR/009 | Draft monograph: Semax | Dr Oisín Rautavaara | Regulatory status is stated without naming the jurisdiction |
| DRAFT-SERMORELIN-M/004 | Draft monograph: Sermorelin | Dr Oswin Yorkstone | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-SERMORELIN-M/006 | Draft monograph: Sermorelin | Dr Ludmila Castellanos-Reid | The compound is supplied under names the monograph does not list |
| DRAFT-SERMORELIN-M/005 | Draft monograph: Sermorelin | Dr Vasilisa Immelmann | The same concept is given three different names in one document |
| DRAFT-SERMORELIN-M/001 | Draft monograph: Sermorelin | Dr Quentin Whitmarsh-Obi | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-SERMORELIN-M/009 | Draft monograph: Sermorelin | Dr Rosalind Grünbaum-Sowande | Doses are expressed in units that differ between sections |
| DRAFT-SS-31-MONOGR/011 | Draft monograph: SS-31 (elamipretide) | Dr Nadezhda Lavrentiev industry | Two factual descriptions of the sponsor's programme are inaccurate |
| DRAFT-SS-31-MONOGR/010 | Draft monograph: SS-31 (elamipretide) | Dr Anselm Thorsby-Nakamura | Registered trials that never reported are absent from the monograph |
| DRAFT-SS-31-MONOGR/008 | Draft monograph: SS-31 (elamipretide) | Dr Wolfram Tollemache | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-SS-31-MONOGR/014 | Draft monograph: SS-31 (elamipretide) | Dr Prosper Vercingetorix | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-SS-31-MONOGR/013 | Draft monograph: SS-31 (elamipretide) | Professor Ekaterina Voskresenskaya-Hill | What happens when the compound is stopped is not addressed |
| DRAFT-SS-31-MONOGR/003 | Draft monograph: SS-31 (elamipretide) | Ivo Mountstephen | The compound is supplied under names the monograph does not list |
| DRAFT-SS-31-MONOGR/016 | Draft monograph: SS-31 (elamipretide) | Rosalind Petrossian | Mechanistic claims for a peptide fragment are carried without evidence that the fragment acts as… |
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