Study Types

As early as the development phase, these studies are crucial for establishing the formulation and determining optimal storage conditions.

They are also useful during industrialisation and required during regulatory registration of clinical and commercial batches to prove that the product remains safe and effective until the expiry date.

In addition, they must be carried out after any change in formulation, manufacturing process or packaging.

Finally, ongoing stability studies are often necessary to monitor the quality of the product on the market and to meet the requirements of the health authorities.

• Raw material, excipient, active ingredient and finished product stability
• Long-term/intermediate/accelerated stability (ICH/VICH)
• R&D (forced degradation/ choice of formulation/ holding time)
• On-going stability
• Pre- and post-marketing stability
• In-use stability
• Transport studies (stress transport, freeze-thaw, etc.)
• ATEX (‘explosion-proof’) stability
• Comparative stability (originator-generic)

The studies conducted in the R&D phase are poorly described in regulatory texts. In this context, Eurofins draws on its experience to provide consultancy services to help define appropriate designs.

Photostability studies should be carried out when it is essential to assess the impact of light exposure on a pharmaceutical or veterinary product. These studies are crucial at the product development stage to identify the potential effects of light on the quality, efficacy and safety of the product. They are also required prior to regulatory registration to ensure that the product remains stable under the light conditions to which it may be exposed during production, storage, distribution and end use. In addition, photostability studies may be required after any change in formulation, packaging or manufacturing process to confirm that these changes do not affect the light stability of the product.

• ICH