New Article Published: The Critical Role of Non GLP Preclinical Studies in Drug Discovery.
Granada, February 17, 2026.
The journey from identifying a bioactive compound to delivering a safe and effective medicine is long, complex, and highly regulated. Before any drug candidate can enter clinical phases, it must undergo rigorous preclinical testing to understand its safety, pharmacokinetic behavior, and overall suitability for further development.
One essential component of this early phase is non‑GLP preclinical research. These exploratory studies provide valuable insights into:
- ADME‑tox profiles (Absorption, Distribution, Metabolism, Excretion, Toxicity).
- Early indications of toxic, genotoxic, or off‑target effects.
- Potential drug–drug interactions.
- Relevant experimental models and optimal administration routes.
Because non‑GLP ADME‑tox assays are more flexible and cost‑effective, they allow teams to evaluate multiple candidates in parallel, apply go/no‑go criteria, and select the strongest lead before entering the more resource‑intensive regulatory phases. Importantly, this approach aligns with the principles of the 3Rs (Replacement, Reduction, Refinement) and the recommendations of RD 1386/2018, emphasizing in vitro studies first to minimize animal use.
Our latest article in Laboratory Animals journal explores:
- The strategic value of non‑GLP preclinical studies.
- Key ADME‑tox assays that de‑risk later development.
- How this phase complements EMA and FDA regulatory requirements.
- Practical insights from the Preclinical Area at Fundación MEDINA.
- CROs offering useful ready‑to‑use models and on‑demand studies.
Non‑GLP preclinical research is not just a preliminary step, it is a critical filter that strengthens decision‑making, reduces downstream failures, and optimizes drug development pipelines.
If you’re working in early drug discovery, pharmacology, or biotech innovation, this content may offer actionable perspectives for refining your workflows.