If you’re asking “What does pre-clinical mean?”, here’s the short answer: it’s the stage before testing in humans where researchers evaluate feasibility, safety, dosing, and mechanism—often using lab and animal models—to decide if a therapy is ready for first-in-human studies.
Pre-clinical is a loaded term. In biopharma it spans discovery through IND/CTA-enabling studies; in medical devices it covers bench, biocompatibility, and GLP safety; in education it refers to pre-clerkship medical training. This guide clarifies all three, with practical links, trusted citations, and imaging-specific context for translational teams.
In drug and device development, pre-clinical work aims to de-risk first-in-human studies by establishing a safe starting dose, clarifying mechanism, and characterizing toxicity and pharmacology. Done well, it saves time, money, and patients from unnecessary risk. In medical education, “pre-clinical” refers to foundational learning before clinical rotations.
“In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals. 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.”
— Preclinical development (Wikipedia)
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Before you file an IND with the FDA or a CTA in the EU, you’ll need a coherent package that supports human exposure. That typically includes:
“The results of preclinical studies must provide detailed information on the drug’s underlying pharmacology and toxicity levels.”
— PPD: Preclinical studies in drug development
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A high-performing pre-clinical plan integrates multiple modalities and methods, each answering a specific go/no-go question.
Discovery and target validation establish mechanism and model selection. Efficacy work in disease-relevant models connects exposure to response and surfaces translational biomarkers that can bridge to humans. PK/PD and ADME define bioavailability, distribution, metabolism, and excretion, informing dose and route. Toxicology and safety pharmacology uncover organ liabilities and define margins to predicted human exposure, sequenced per ICH M3(R2). Device programs layer in bench characterization, biocompatibility, and GLP animal work as needed.
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Model selection drives translation. Choose constructs that mirror the intended patient population and human biology—then plan for external validation. Ethical conduct is integral: implement the 3Rs—Replacement, Reduction, Refinement—and justify species, group sizes, and endpoints. Many IND/CTA packages include studies in two species for small molecules; large-animal models may be appropriate for devices or complex biologics.
For additional context on nonclinical expectations, see EMA non-clinical guidance and region-specific standards like OECD Guidelines.
Imaging strengthens pre-clinical decision-making with non-invasive, longitudinal endpoints that align with clinical readouts. Typical use cases include volumetric and functional MRI in oncology, PET/SPECT tracers for target engagement, structural/functional MRI and tracer-based methods in neurology, and CT/MRI for device positioning and healing dynamics. Robust pre-clinical imaging harmonizes acquisition, performs phantom-based QC, and maps features to clinical endpoints—foundational for early-phase success and eventual registrational trials.
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In medical schools, “pre-clinical” refers to foundational learning preceding clinical rotations—basic sciences integrated with early clinical skills and reasoning. For example, NYU Grossman School of Medicine’s preclerkship spans systems-based modules and bedside competencies; see their preclerkship curriculum.
Pre-clinical spans the decisive work before first-in-human: understanding mechanism, selecting dose and route, building a safety margin, and linking biomarkers and imaging endpoints to clinical readouts. Align to FDA/EMA expectations, apply ICH M3(R2), implement the 3Rs, and make every study answer a specific translational question. That’s how you reach IND/CTA with confidence—and reduce late-stage surprises.
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What’s the difference between pre-clinical and non-clinical?
They’re often used interchangeably; “non-clinical” typically refers to studies not involving humans (in vitro/in vivo), while “pre-clinical” emphasizes studies intended to support first-in-human.
Do all drugs require animal studies?
Most IND-enabling programs include animal studies, though alternatives and new approach methodologies are growing. Ethical frameworks like the 3Rs guide when and how animals are used.
How important is imaging in pre-clinical?
Very. It supports non-invasive, longitudinal endpoints and improves translational fidelity—especially when acquisition/analysis mirrors clinical protocols.
What guidance should I follow for timing and content?
See ICH M3(R2), FDA IND, and EMA non-clinical.
Reviewed by: Pilar Flores Gastellu on October 30, 2025