Evidence synthesis · §4
Reconstitution practice and delivered dose — summary of findings
Outcome-by-outcome summary with effect, certainty and the reason for each downgrade.
§4Summary of findings
§4.1Summary of findings
Table 7. Summary of findings for Reconstitution practice and delivered dose.
| Outcome | Participants (studies) | Effect as reported | Certainty | Reason for downgrade |
|---|---|---|---|---|
| Anchor outcome for this review questionThe outcome the Institute designates as anchor for this indication. | 37,696 (24) | Moderate certainty evidence, principally analytical rather than clinical, indicates that three distinct errors compound in ordinary reconstitution… | Moderate | indirectness |
| Discontinuation for adverse eventsReported as a summary-of-findings row rather than in a tolerability annex, following a public submission. | 27,196 (23) | Reported per contributing trial; see the included-studies table | Moderate | publication bias |
| Serious adverse eventsEvent counts are low; the estimate is imprecise by construction. | 37,031 (24) | Reported per contributing trial; see the included-studies table | Low | imprecision |
| Any adverse eventAscertained by spontaneous report in the contributing trials. | 34,415 (22) | Reported per contributing trial; see the included-studies table | Low | indirectness, imprecision |
| Certainty ratings describe confidence in the effect estimate for the stated outcome. They are not recommendations and do not transfer between outcomes. | ||||
§4.2Forest plot
Study estimatePooled estimate
§4.3Certainty assessment for the anchor outcome
Table 8. Reasoning recorded against each certainty domain for the anchor outcome.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | Serious | An outcome that would answer the question was not measured in any contributing trial. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
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.
- Manning MC, Chou DK, Murphy BM, Payne RW, Katayama DS. Stability of protein pharmaceuticals: an update. Pharmaceutical Research 2010;27(4):544–575. doi:10.1007/s11095-009-0045-6 · PMID 20143256
- Wang W, Nema S, Teagarden D. Protein aggregation — pathways and influencing factors. International Journal of Pharmaceutics 2010;390(2):89–99. doi:10.1016/j.ijpharm.2010.02.025 · PMID 20188795
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.
Compound Evidence Institute · CEI-ES-024/4 · https://compoundevidence.com/syntheses/reconstitution-practice-and-content/summary-of-findings/ · retrieved 30 July 2026