Consultation record
Submissions accepted — page 14
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 14 of 23
Table 1. Submissions with this disposition, on this page.
| Reference | Consultation | Respondent | Point raised |
|---|---|---|---|
| DRAFT-NAD-PLUS-MON/008 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Vittoria Ylönen | A near-isobaric analogue is not distinguished by the identity determination described |
| DRAFT-NAD-PLUS-MON/009 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Anselm Thorsby-Nakamura | The analytical section assumes a reference standard that is not generally available |
| DRAFT-NAD-PLUS-MON/004 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Bertrand Steenkamp-Ferreira | Every contributing trial shares one sponsor and the monograph does not say so |
| DRAFT-NAD-PLUS-MON/003 | Draft monograph: NAD+ (nicotinamide adenine dinucleotide) | Dr Anselm Ashworth-Danquah | Regulatory status is stated without naming the jurisdiction |
| DRAFT-ORAL-SEMAGLU/005 | Draft monograph: Semaglutide, oral | Leonhard Achterberg | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-ORAL-SEMAGLU/009 | Draft monograph: Semaglutide, oral | Dr Rurik Underhill-Okafor | The compound is supplied under names the monograph does not list |
| DRAFT-ORAL-SEMAGLU/002 | Draft monograph: Semaglutide, oral | Ms Rhiannon Okoye-Vandergraaf | The indication table mixes approved indications with uses for which the compound is merely supplied |
| DRAFT-ORAL-SEMAGLU/004 | Draft monograph: Semaglutide, oral | Dr Kolawole Isaksen-Balogun | Registered trials that never reported are absent from the monograph |
| DRAFT-ORAL-SEMAGLU/006 | Draft monograph: Semaglutide, oral | Dr Ndidi Ravensworth-Ilunga | Doses are expressed in units that differ between sections |
| DRAFT-PETRELINTIDE/012 | Draft monograph: Petrelintide | Professor Chukwuemeka Rasmussen-Adeyemi | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-PETRELINTIDE/002 | Draft monograph: Petrelintide | Quentin Gwynne-Sarpong | The monograph does not tell a reader that a stated mass may be substantially counter-ion and water |
| DRAFT-PETRELINTIDE/011 | Draft monograph: Petrelintide | Dr Jerome Lavrentiev | The certainty rating for the principal assessed outcome cannot be traced to the contributing trials |
| DRAFT-PETRELINTIDE/004 | Draft monograph: Petrelintide | Dr Ottoline Fitzgerald-Nwosu | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-PETRELINTIDE/015 | Draft monograph: Petrelintide | Kolawole Oppenheimer-Ade | A purity figure from a certificate is quoted as though it were a content figure |
| DRAFT-PETRELINTIDE/010 | Draft monograph: Petrelintide | Radoslava Palmgren-Kofi | Regulatory status is stated without naming the jurisdiction |
| DRAFT-PETRELINTIDE/003 | Draft monograph: Petrelintide | Dr Zebedee Zaleski-Mbeki | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-PETRELINTIDE/014 | Draft monograph: Petrelintide | Dr Delphine Ravensworth | Quantitative claims are reproduced without the method that produced them |
| DRAFT-PRAMLINTIDE-/001 | Draft monograph: Pramlintide | Dr Lorcan Whitmarsh-Obi | The compound is supplied under names the monograph does not list |
| DRAFT-PRAMLINTIDE-/011 | Draft monograph: Pramlintide | Dr Katarzyna Yorkstone | What happens when the compound is stopped is not addressed |
| DRAFT-PRAMLINTIDE-/003 | Draft monograph: Pramlintide | Dr Leonhard Quenneville | The search date is not on the face of the document |
| DRAFT-PRAMLINTIDE-/014 | Draft monograph: Pramlintide | Dr Jacinta Steenkamp-Ferreira | The pharmacokinetic section does not connect half-life to the dosing schedule |
| DRAFT-PRAMLINTIDE-/013 | Draft monograph: Pramlintide | Dr Mordecai Bellingham-Ojo | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-PRAMLINTIDE-/007 | Draft monograph: Pramlintide | Dr Fenella Steenkamp-Ferreira | Quantitative claims are reproduced without the method that produced them |
| DRAFT-PRAMLINTIDE-/015 | Draft monograph: Pramlintide | Quentin Gwynne-Sarpong | Doses are expressed in units that differ between sections |
| DRAFT-PT-141-MONOG/007 | Draft monograph: PT-141 (bremelanotide) | Dr Fenella Steenkamp-Ferreira | Regulatory status is stated without naming the jurisdiction |
| DRAFT-PT-141-MONOG/009 | Draft monograph: PT-141 (bremelanotide) | Nkechi Larsson-Ekwueme | Effect estimates are given without naming the comparator |
| DRAFT-PT-141-MONOG/006 | Draft monograph: PT-141 (bremelanotide) | Dr Stellan Cholmondeley-Ade | The population to which the headline estimate applies is not stated with the estimate |
| DRAFT-PT-141-MONOG/011 | Draft monograph: PT-141 (bremelanotide) | Dr Jolanta Uttridge | The analytical section assumes a reference standard that is not generally available |
| DRAFT-PT-141-MONOG/005 | Draft monograph: PT-141 (bremelanotide) | Xiomara Fairweather-Duru | Absence of evidence is presented in a form a reader will take as negative evidence |
| DRAFT-PT-141-MONOG/002 | Draft monograph: PT-141 (bremelanotide) | Dr Kolawole Isaksen-Balogun | A purity figure from a certificate is quoted as though it were a content figure |
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