Before human trials can begin, extensive preclinical research is conducted to assess the safety, efficacy, and biological activity of potential therapeutic products. Our comprehensive preclinical approach includes drug discovery and screening to identify promising compounds for further testing. In vitro and in vivo testing are used to evaluate pharmacokinetics, toxicity, and safety in cell cultures and animal models. We also focus on formulation development to optimize drug delivery and prepare for clinical use, followed by regulatory preclinical submissions to ensure compliance with agencies like the FDA and EMA.
Key Activities:
- Drug Discovery & Screening – Identifying potential therapeutic compounds.
- In Vitro Testing – Laboratory testing using cell cultures to analyze pharmacokinetics and toxicity.
- In Vivo Testing – Animal studies to assess the safety profile and biological activity.
- Formulation Development – Optimizing drug formulations for clinical use.
- Regulatory Preclinical Submission – Preparing and submitting Investigational New Drug (IND) applications to regulatory agencies (e.g., FDA, EMA).
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