Tag: clinical trial phase analysis

Combining Phase 0 with Adaptive Phase 1 Trials: Strategies for Seamless Transition Combining Phase 0 and Adaptive Phase 1 Trials: A Seamless Early Development Strategy Introduction Phase 0 trials provide early human pharmacokinetic and target engagement data. Phase 1 trials explore safety and dose tolerance. Combining these phases into a seamless development strategy using adaptive…

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PET Imaging and Radiolabeling Techniques in Phase 0 Oncology Studies Using PET Imaging and Radiolabeling in Phase 0 Oncology Trials Introduction 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…

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Common Pitfalls in Phase 0 Trial Design and How to Avoid Them Common Pitfalls in Phase 0 Trial Design and How to Avoid Them Introduction 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…

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Writing SOPs and Protocols for GLP-Compliant Phase 0 Trials How to Write Protocols and SOPs for GLP-Compliant Phase 0 Trials Why GLP Matters in Phase 0 Microdosing Studies 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…

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Integrating In Silico Modeling and PBPK with Phase 0 Studies Integrating In Silico Modeling and PBPK with Phase 0 Studies Introduction: Enhancing Predictive Power of Early Trials 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…

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Global Regulatory Landscape for Phase 0 Studies: A Comparative Guide Global Regulatory Landscape for Phase 0 Clinical Trials: A Comparative Overview Introduction: Regulatory Oversight in Early Human Studies Phase 0 trials—or exploratory microdosing studies—may be low-risk, but they are still subject to stringent regulatory oversight. Each country has unique pathways for approval, risk classification, and…

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How to Use Phase 0 Data to Inform Go/No-Go Decisions in Drug Development Making Go/No-Go Decisions Using Phase 0 Trial Data Why Early Decision-Making Is Critical Drug development is time-consuming and resource-intensive. Making informed go/no-go decisions as early as possible can prevent costly failures later. Phase 0 trials, through microdosing and focused pharmacokinetic/pharmacodynamic (PK/PD) evaluations,…

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Phase 0 Trial Setup: Team Roles, Site Selection, and Volunteer Management Setting Up a Phase 0 Trial: Teams, Sites, and Volunteer Management Why Setup Matters in Phase 0 Trials While Phase 0 studies are shorter and involve fewer participants than traditional trials, their setup requires meticulous planning and coordination. These trials often involve advanced technologies…

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Clinical Pharmacokinetics in Phase 0: How to Analyze Microdose Data How to Analyze Pharmacokinetic Data in Phase 0 Microdosing Trials Introduction: Why Pharmacokinetics (PK) Matters in Phase 0 The main objective of most Phase 0 trials is to gather pharmacokinetic (PK) data in humans using microdose levels. These early insights help answer crucial questions such…

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Bioanalytical Methods and Assay Development for Microdose Studies Bioanalytical Techniques and Assay Development for Phase 0 Microdosing Trials Why Bioanalysis is Crucial in Microdose Studies In Phase 0 trials, drug doses are so small that plasma concentrations are often in the picogram to nanogram range. This means standard analytical methods may not be sensitive enough…

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