In general, regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe usually require comprehensive pre-clinical testing to ensure the safety of new products before they can advance to clinical trials. Toxicity studies are also performed. To determine the potential harmful effects of the encapsulated substance on various organs and systems of the body.

Hi, the need for additional in vivo and toxicity studies for a new formulation of a well-known drug product depends on several factors, including the extent of changes in the formulation and the availability of existing data (case-by-case).

Changes in Formulation Components

If the new formulation contains different excipients or especially novel excipients not previously used in approved formulations, additional toxicity studies may be required to evaluate the safety of these new components. This is particularly important if the new excipients have not been extensively studied or used in approved drug products.

Changes in Drug Release/Dissolution Profile

Significant changes in the drug release or dissolution profile compared to the approved formulation may necessitate additional bioavailability and pharmacokinetic studies. These studies help assess the impact of the new formulation on drug absorption and exposure.

Changes in Drug Stability or Impurity Profile

If the new formulation alters the drug's stability or impurity profile, additional toxicity studies may be required to evaluate the safety of any new impurities or degradation products.

Existing Data and Regulatory Guidance

If extensive data already exists for the approved formulation, including toxicology studies and human clinical data, and the new formulation does not significantly alter the drug's performance or safety profile, additional in vivo or toxicity studies may not be necessary. However, regulatory agencies may still require certain studies based on their guidelines and the specific changes in the formulation.

In general, if the new formulation represents a significant change from the approved formulation, additional in vivo and toxicity studies may be required to demonstrate safety and bioequivalence before clinical trials. However, the extent of these studies can be minimized by leveraging existing data and following regulatory guidance specific to the drug product and the proposed changes.

Hope it helps

Best regards

Tomasz

Yes, it's need in vivo and toxicity test before clinical trials