Safety
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Clinical Development – Safety
Investigation of cutaneous safety is a critical component of product development for topical and systemic products and transdermal systems.
At Eurofins bioskin we are experienced in the design and conduct of the entire spectra of cutaneous safety studies and offer a battery of safety tests required for assessment of products which are applied locally.
In addition we plan and conduct studies evaluating systemic safety (e.g. PK or systemic absorption, ECGs, clinical chemical parameters) and histological/immunohistochemical effects.
Designs for evaluation of safety include:
- Dermal tolerability (diverse models)
- Skin sensitization potential
- Phototoxic and photosensitization potential
- Systemic absorption and pharmacokinetics (PK)
- Skin atrophogenic potential
- Dermal tolerability and sensitization potential of transdermals