Early stages of pharmacovigilance in drug development:
1. Preclinical Research and Early Safety Assessment
Pharmacovigilance experts assess potential safety concerns in this initial phase based on non-human data. The following elements are integral to this phase:
- Pharmacokinetics (PK): Understanding how the drug is absorbed, distributed, metabolised, and excreted (ADME) in preclinical models is key to predicting potential toxicities.
- Pharmacodynamics (PD): Investigating the drug's effects on the body helps identify therapeutic targets and predict side effects.
Key Activities in Preclinical Pharmacovigilance:
- Safety Pharmacology: Evaluating the drug's effects on vital organ systems (e.g., cardiovascular, and respiratory) to detect early signs of toxicity.
- Toxicology Studies: These involve animal acute and chronic toxicity tests to determine safe dose ranges and highlight potential risks.
- Early Signal Detection: Pharmacovigilance experts use predictive models and biomarkers to assess early safety signals that could guide dosing strategies and safety measures in clinical trials.
