In-use stability of reconstituted peptide solutions — amendment log
Every change made since protocol registration, with its date and reason.
§5Amendment log
Every change made to this review after protocol registration is recorded below with its date and its reason. A change that is not in this log did not happen. The Institute publishes the log in full, including changes that did not alter a conclusion, because a reader cannot judge which changes matter unless all of them are visible.
§5.1Amendment log
Table 9. Amendments to this review since protocol registration.
| Date | Version | Amendment | Record |
|---|---|---|---|
| 11 Jul 2024 | 0.1 | Protocol registered | The review protocol was registered with the Institute’s secretariat before the search was executed. No change to the review question was made after registration. |
| 16 Sep 2024 | 2.1 | Outcome added | An additional outcome was added at the request of a public comment-period respondent. The addition is recorded here because it was made after protocol registration and is therefore post hoc. |
| 04 Nov 2024 | 2.2 | Search re-run | The search was re-run to the current cycle date. Newly identified records were screened against the registered criteria without modification of those criteria. |
| 11 Apr 2025 | 2.3 | Correction issued | A numerical error in one summary-of-findings row was corrected. The direction of the conclusion was unaffected and the correction is recorded in full in the corrections log. |
| 08 Oct 2025 | 2.0 | Analysis method changed | The pooling method was changed from a fixed-effect to a random-effects model following observation of between-study heterogeneity exceeding the pre-specified threshold. |
| Current version 2.3, ratified in the 2024 Q3 assessment cycle. | |||
§5.2Clinical study report requests
Table 10. Clinical study reports requested for the contributing trials, and the outcome of each request. Refusals are recorded because a review that does not record them presents the sponsor's disclosure decision as the Institute's own.
| Trial | Requested | Outcome |
|---|---|---|
| ACHIEVE-1 | 18 May 2024 | Supplied on request |
| ACHIEVE-2 | 11 May 2024 | Supplied on request |
| ATTAIN-1 | 28 Apr 2024 | Supplied on request |
| ATTAIN-2 | 10 Jun 2024 | Redirected to a data-access portal |
| ECNO-PH3-CN-OBESITY | 25 Jun 2024 | Supplied on request |
| ECNO-PH3-CN-T2D | 18 May 2024 | Supplied on request |
| ESSENCE | 06 Jun 2024 | Redirected to a data-access portal |
| EXENATIDE-GE-PD | 12 May 2024 | Redirected to a data-access portal |
§5.3Superseded versions
Superseded versions of this review remain published at a stable address, are marked as superseded, and link forward to the current version. The current version links back to each of them. That practice was adopted following a submission that a document cited in the literature must remain retrievable in the form in which it was cited; the reasoning is published on the corrections policy disposition page.
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.
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q1A(R2) Stability Testing of New Drug Substances and Products. ICH Harmonised Tripartite Guideline 2003;Step 4 version. 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.