Tag: clinical trial phase process

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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Step-by-Step Guide to Regulatory Submissions for Phase 0 Trials Step-by-Step Guide to Regulatory Submissions for Phase 0 Clinical Trials Introduction: Regulatory Oversight in Phase 0 Trials Phase 0 trials, although short and low-risk, are still governed by regulatory frameworks. Before starting human studies, sponsors must obtain authorization from national health authorities. This ensures that human…

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Ethics and Safety in Phase 0 Trials: What You Need to Know Ethics and Safety in Phase 0 Trials: What Every Researcher Should Know Introduction: Ethics at the Heart of Human Research Even though Phase 0 trials involve microdoses and no therapeutic intent, they are still clinical trials involving human participants. This means they must…

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