Glossary
Preclinical Development
What is Preclinical Development?
Preclinical development is the stage of research that occurs before clinical trials in humans, during feasibility, testing, and safety data are collected, typically through laboratory studies.
The main goals of preclinical development are:
- To determine a safe starting dose for first-in-human studies
- Assess potential toxicity of the product, which can include new drugs, devices, and diagnostics.
- Develop a new drug scale up
- Support the intended clinical trail
What is the difference between preclinical development and clinical development?
| Preclinical Development | Clinical Development |
|---|---|
| Occurs before testing in humans | Involves testing in human subjects |
| Uses laboratory animals and in vitro studies | Conducted in human clinical trials |
| Aims to determine a safe starting dose and assess potential toxicity | Evaluates efficacy and further assesses safety in patients |
| Generates data for Investigational New Drug (IND) application | Generates data for New Drug Application (NDA) for marketing approval |
| Adheres to Good Laboratory Practices (GLP | Adheres to Good Clinical Practices (GCP) |
| Includes pharmacology, pharmacokinetics, and toxicology studies | Divided into phases (Phase 1, 2, 3, 4) |
| Typically involves rodent and non-rodent animal models | Involves human subjects, often starting with healthy volunteers |
Why is preclinical development important in pharma?
Preclinical development is essential for evaluating the safety and efficacy of drug candidates before human testing. It identifies potential adverse effects, determines safe dosages, and provides preliminary evidence for further testing. Regulatory agencies require comprehensive preclinical data to ensure safety for human trials, helping companies comply with legal standards. Early issue identification saves time and resources, avoiding costly failures in later phases. Additionally, preclinical data informs clinical trial design and strengthens intellectual property by supporting patents. In summary, preclinical development is vital for ensuring that safe and effective drug candidates reach the market.
