Draft monograph: Gonadorelin — disposition

§3Disposition and amendments

§3.1Disposition table

Table 1. Every submission with its disposition. Each row links to the submission in full.

§3.2Summary by disposition

Table 2. Counts by disposition, with the meaning of each.

§3.3Resulting amendments

1. Trials are described as terminated where they completed as planned — arising from DRAFT-GONADORELIN-/001. Trial status now uses a fixed vocabulary defined in the glossary, and where the reason for stopping is not evidenced by a document the Institute holds, the status is recorded as stopped with the reason not established rather than assigned.
2. The compound is supplied under names the monograph does not list — arising from DRAFT-GONADORELIN-/002. The synonym list is extended to include every name the Institute can evidence from a document it holds, each recorded with its source. Names asserted without a supporting document are not added, and the distinction is stated at the head of the list.
3. The absence of a rare harm in the trial set is presented as reassurance — arising from DRAFT-GONADORELIN-/004. Wherever the monograph reports that an event was not observed, it now states the total exposure and the frequency the contributing trials could have detected, so that the absence is read as the limit of the evidence rather than as a finding.
4. The difference between pulsatile and continuous administration is not addressed — arising from DRAFT-GONADORELIN-/005. The administration schedule is now stated with every effect estimate for these compounds, and the pharmacology section describes the dependence of direction on schedule.
5. A purity figure from a certificate is quoted as though it were a content figure — arising from DRAFT-GONADORELIN-/006. Purity and content are now reported in separate rows with separate definitions, and the monograph states that a purity figure sets no bound on content and that a content figure requires a determination against a standard of assigned content.
6. The monograph does not tell a reader that a stated mass may be substantially counter-ion and water — arising from DRAFT-GONADORELIN-/007. The monograph now states, at the point where vial contents are first mentioned, that a mass figure is uninterpretable unless it states whether it is peptide content or total solids, and cross-references the content standard in the analytical series.
7. The route of administration studied is not the route in which the compound is supplied — arising from DRAFT-GONADORELIN-/008. The assessed-outcome table now carries the studied route in every row, and a standing note appears wherever the supplied presentation differs from it.
8. Every contributing trial shares one sponsor and the monograph does not say so — arising from DRAFT-GONADORELIN-/009. Sponsor concentration is now stated with the certainty rating, and the monograph records how many independent sponsors contributed evidence to each assessed outcome.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

1. International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.