Excipients
Facilitating data sharing on the tolerability of pharmaceutical excipient formulations
Excipients are essential components of drug products, but they are also potential toxicants.
Understanding the levels of toxicity of pharmaceutical excipients is a crucial part of pharmaceutical drug development and often requires risk assessments to establish permissible and safe limits for these substances.
Our solution
The aim of the Vitic Excipients data sharing initiative is to facilitate the anonymous sharing of excipient and vehicle toxicity data.
The initiative member gains access to this proprietary formulation data helping you to refine your experiments, minimize animal testing and support regulatory submissions.
Key highlights
Promotes the use of alternative methods for assessing chemicals
Participate in a data sharing consortium that actively contributes towards the reduction of animal testing. The initiative continues to aid industry data sharing and support REACH submissions by making propriety data easily accessible via a custom curated database.
Refine your experiments
Utilise proprietary data and reduce duplication of effort by quickly, searching, storing, and retrieving agreed AI/PDE data from our structure searchable database.
Make more informed decisions
We act as the honest broker; expertly curating member donations and allowing a level of anonymity.
Through our systematic peer-review process, you can be guaranteed a high-quality dataset that you can be confident using.
Regulatory support
REACH
Among other aims, the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) aims to reduce animal testing by promoting the use of alternative methods of assessing chemicals.
The Excipients data sharing initiative continues to aid industry data sharing and support REACH submissions by making propriety data easily accessible via a custom curated database.
Discover how you can become part of the Excipients data sharing consortium.
Related publications
Paper
- Nov 2022
- Complex Nitrosamines, Data sharing, Nitrosamine impurity risk assessment
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