Preclinical Studies

Phase 0 trials offer real human PK data at microdose levels—but alone, they can’t predict full-dose behavior for every compound. To bridge this gap, researchers increasingly rely on in silico modeling and physiologically based pharmacokinetic (PBPK) simulations. These computational approaches improve dose predictions, inform study design, and support go/no-go decisions—especially when clinical data is sparse.
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Although Phase 0 trials involve human subjects and follow GCP, they also rely heavily on nonclinical data, analytical labs, and sample handling—all of which fall under Good Laboratory Practice (GLP) principles. Writing clear, consistent, and compliant protocols and SOPs ensures data integrity, regulatory acceptability, and operational efficiency throughout the microdosing study.
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Phase 0 trials are small, fast, and cost-effective—but they must be carefully designed to yield meaningful data. Because these microdosing studies are non-therapeutic, researchers sometimes underestimate their complexity. Design missteps can compromise data quality, delay development, or even invalidate the study. This article highlights the most common pitfalls and offers practical ways to avoid them.
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Phase 0 oncology trials aim to generate early human data to guide therapeutic development. One of the most powerful tools in these trials is Positron Emission Tomography (PET) imaging, especially when paired with radiolabeled compounds. PET enables researchers to visualize how a drug behaves in tumors, confirming whether it reaches the target, engages it, and stays long enough to exert an effect—all at microdose levels.
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Phase 0 trials offer early insight into drug behavior in humans using sub-therapeutic microdoses. First-in-Human (FIH) trials, on the other hand, initiate therapeutic dosing to assess safety and tolerability. Bridging the gap between these two stages requires careful planning, regulatory awareness, and a clear understanding of pharmacology. This article explores the key distinctions and offers guidance on how to transition safely and effectively.
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