Pre Clinical Studies
The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and diagnostics.
- Ethical Committee Certification from Approved Laboratory
- Determination of Pharmacokinetic Parameters for API & Finished Dosage Forms.
- Each class of product may undergo different types of preclinical research :
- Pharmacodynamics (what the drug does to the body) (PD)
- Pharmacokinetics (what the body does to the drug) (PK)
- ADME
- Toxicology testing
