Evidence map›Paper›PMID 36365143›Full record

ReviewPharmaceutics2022

Drug Stability: ICH versus Accelerated Predictive Stability Studies.

Olga González-González, Irving O Ramirez, Bianca I Ramirez, Peter O'Connell, Maria Paloma Ballesteros, Juan José Torrado, Dolores R Serrano

Abstract readReview
In one paragraph

Review in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

70 citing papers in PubMed.

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  16. Development of a 50% (w/v) aluminium chloride hexahydrate solution as haemostatic agent.European journal of hospital pharmacy : science and practice · 2025
    Article
  17. Stability study of topotecan in ophthalmic prefilled syringes for intravitreal delivery.European journal of hospital pharmacy : science and practice · 2025
    Article
  18. Article
  19. Article
  20. Article

10 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Olga González-GonzálezDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.
Irving O RamirezDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.
Bianca I RamirezDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.
Peter O'ConnellDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.
Maria Paloma BallesterosDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.
Juan José TorradoDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.ORCID 0000-0002-7823-1904
Dolores R SerranoDepartamento de Farmacia Galénica y Tecnología Alimentaria, Facultad de Farmacia, Universidad Complutense de Madrid, Plaza Ramón y Cajal, s/n, 28040 Madrid, Spain.ORCID 0000-0002-0475-8420

Funding

Complutense University of Madrid 910939European Society of Clinical Microbiology and Infectious Diseases year 2021, ID: 16306
6 · The paper itself

Abstract

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and the United States to facilitate the mutual acceptance of stability data that are sufficient for registration by the regulatory authorities in these jurisdictions. Overall, ICH stability studies involve a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture. The long-term testing should be performed over a minimum of 12 months at 25 °C ± 2 °C/60%

Indexed as

ASPextemporaneous compoundingstability

Identifiers

PMID36365143
PMCPMC9693625

What OpenQuestion holds

Textmetadata
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Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.