Consultation record

Submissions accepted in part — page 6

Part of the submission is accepted and part is not. The secretariat response states which part is which and on what ground the remainder was declined.

Submissions

390 documents · page 6 of 13

Table 1. Submissions with this disposition, on this page.

Reference	Consultation	Respondent	Point raised
DRAFT-CAGRILINTIDE/009	Draft monograph: Cagrilintide	Dr Piotr Hollingworth	The analytical section is longer than the clinical assessment it accompanies
DRAFT-CAGRILINTIDE/010	Draft monograph: Cagrilintide	Anselm Mountstephen	References should carry a persistent identifier for every cited source
DRAFT-CAGRILINTIDE/013	Draft monograph: Cagrilintide	Dr Theodora Trelawney	Anti-drug antibody data are omitted
DRAFT-CJC-1295-MON/002	Draft monograph: CJC-1295	Dr Yaa Kettlewell	Point estimates are given without an interval
DRAFT-CJC-1295-MON/006	Draft monograph: CJC-1295	Dr Liesbeth Zaleski-Mbeki	The analytical section is longer than the clinical assessment it accompanies
DRAFT-CJC-1295-MON/008	Draft monograph: CJC-1295	Dr Zdenka Nyquist-Obiora	The preclinical section is extensive and the clinical section is not
DRAFT-CJC-1295-MON/011	Draft monograph: CJC-1295	Dr Theodora Ingelbrecht	The recorded evidence gaps omit outcomes a reader would consider material
DRAFT-CJC-1295-MON/013	Draft monograph: CJC-1295	Leonhard Achterberg	Anti-drug antibody data are omitted
DRAFT-DSIP-MONOGRA/001	Draft monograph: DSIP	Dr Abimbola Sotomayor-Ekwueme	Storage and reconstitution guidance is given without stating what it rests on
DRAFT-DSIP-MONOGRA/003	Draft monograph: DSIP	Dr Frideswide Nordhagen	The interaction section lists mechanisms rather than interactions
DRAFT-DULAGLUTIDE-/001	Draft monograph: Dulaglutide	Dr Lorcan Whitmarsh-Obi	The analytical section is longer than the clinical assessment it accompanies
DRAFT-ECNOGLUTIDE-/006	Draft monograph: Ecnoglutide	Dr Henrike Jastrzębska	The analytical section is longer than the clinical assessment it accompanies
DRAFT-EPITHALON-MO/001	Draft monograph: Epithalon	Ms Rhiannon Okoye-Vandergraaf	The document is unreadable without specialist training
DRAFT-EPITHALON-MO/004	Draft monograph: Epithalon	Dr Henrike Jastrzębska	The preclinical section is extensive and the clinical section is not
DRAFT-EXENATIDE-MO/003	Draft monograph: Exenatide	Dr Frideswide Nordhagen	The interaction section lists mechanisms rather than interactions
DRAFT-EXENATIDE-MO/004	Draft monograph: Exenatide	Dr Liesbeth Zaleski-Mbeki	The analytical section is longer than the clinical assessment it accompanies
DRAFT-EXENATIDE-MO/008	Draft monograph: Exenatide	Dr Matthias Wintringham industry	The monograph should reproduce the approved labelling rather than paraphrase it
DRAFT-GHRP-2-MONOG/003	Draft monograph: GHRP-2	Dr Vittoria Quintanilha	Trials are described as terminated where they completed as planned
DRAFT-GHRP-2-MONOG/006	Draft monograph: GHRP-2	Eamon Sandringham-Adu	References should carry a persistent identifier for every cited source
DRAFT-GHRP-6-MONOG/003	Draft monograph: GHRP-6	Ms Rhiannon Okoye-Vandergraaf	The document is unreadable without specialist training
DRAFT-GHRP-6-MONOG/008	Draft monograph: GHRP-6	Dr Theodora Ingelbrecht	The recorded evidence gaps omit outcomes a reader would consider material
DRAFT-GHRP-6-MONOG/010	Draft monograph: GHRP-6	Dr Lorcan Whitmarsh-Obi	The mechanism section is written with more confidence than the clinical section it precedes
DRAFT-GLUTATHIONE-/007	Draft monograph: Glutathione	Dr Liesbeth Nordhagen industry	The monograph should reproduce the approved labelling rather than paraphrase it
DRAFT-GONADORELIN-/001	Draft monograph: Gonadorelin	Dr Jozef Brandvold-Achterberg	Trials are described as terminated where they completed as planned
DRAFT-HEXARELIN-MO/001	Draft monograph: Hexarelin	Dr Hyacinth Drakeford-Amadi	The interaction section lists mechanisms rather than interactions
DRAFT-HEXARELIN-MO/004	Draft monograph: Hexarelin	Dr Vittoria Quintanilha	Trials are described as terminated where they completed as planned
DRAFT-IGF-1-LR3-MO/006	Draft monograph: IGF-1 LR3	Dr Zdenka Nyquist-Obiora	The analytical section is longer than the clinical assessment it accompanies
DRAFT-IGF-1-LR3-MO/008	Draft monograph: IGF-1 LR3	Dr Liesbeth Zaleski-Mbeki	The mechanism section is written with more confidence than the clinical section it precedes
DRAFT-IPAMORELIN-M/001	Draft monograph: Ipamorelin	Dr Yaa Kettlewell	Point estimates are given without an interval
DRAFT-IPAMORELIN-M/003	Draft monograph: Ipamorelin	Dr Abimbola Sotomayor-Ekwueme	Storage and reconstitution guidance is given without stating what it rests on

page 6 of 13