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19 de ago. de 2020 · What is Stability Storage? Stability storage is the placement of samples into environmentally controlled chambers to determine how the quality of the substance or product varies with time under the influence of environmental factors such as temperature, humidity and light.
This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information to be submitted for abbreviated or abridged applications, variations and clinical trial applications.
19 de fev. de 2014 · This paper provides a comprehensive overview of stability-related aspects of quantitative bioanalysis and recommends science-based best practices, covering small and large molecules as well as chromatographic and ligand-binding assays. It addresses general aspects, such as the use of reference values, transferability and treatment of ...
- Nico van de Merbel, Natasha Savoie, Manish Yadav, Yoshiaki Ohtsu, Joleen White, Maria Francesca Ricc...
- 2014
This document aims to set out uniform statements on storage conditions for inclusion in the labelling of medicinal products and to define when they apply. It is intended as an annex to stability guidelines and relates to marketing authorisations for all product categories.
Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. The testing should cover, as appropriate, the physical, chemical, biological, and
12 de jul. de 2024 · Stability storage involves specialized enclosures such as stability chambers and walk-in rooms to store and evaluate the impact of environmental conditions on product stability over time.
ICH walk-in stability chambers, accelerated and bespoke storage conditions and assessments, and stability analysis for drug substance or drug product testing.
