Basic Concepts and Requirements of Galenic Formulations

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Non-clinical safety studies aim to:

• Explore the response at up to maximum achievable doses.
• Detect potential hazards.
• Generate data so a risk assessment can be made.
• Help select the dose for the first clinical studies.
• Suggest ‘markers’ to monitor safety in humans.
• Provide a foundation for specific tests later on.

The safety studies cannot guarantee safety in humans. Also they may not be able to predict how humans respond or to define a mechanism for the induced changes. Safety testing can assess the margins of safety in animal and human data. Considerations for this type of tests are:

• The dose administered,
• The extent and duration of systemic exposure,
• Daily systemic exposure,
• The exposure and identity of metabolites,
• The exposure in target organs.

Safety testing is carried out on the active substance as well as on all related substances, solvents, degradation products, excipients, other active materials and extractives which are part of the final formulation.