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How to Design a Microdosing Study in Phase 0 Trials A Step-by-Step Guide to Designing a Microdosing Study for Phase 0 Trials What is a Microdosing Study? A microdosing study involves the administration of extremely low, sub-therapeutic doses of a drug to human subjects to evaluate early pharmacokinetic (PK) and pharmacodynamic (PD) behavior. These studies…
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Site Selection and Infrastructure Needs for Early-Phase Trials Site Selection and Infrastructure Needs for Early-Phase Trials Introduction Early-phase clinical trials—especially Phase 1 studies—require specialized environments for participant safety, data integrity, and regulatory compliance. Choosing the right site is a critical success factor. From facility readiness to investigator experience, this tutorial explores how to select, prepare,…
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Transition Criteria from Phase 1 to Phase 2 Clinical Trials How Drugs Move from Phase 1 to Phase 2: Transition Criteria and Developmental Milestones Introduction The transition from Phase 1 to Phase 2 is one of the most critical decision points in drug development. It marks the move from initial human safety testing to early…
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Regulatory Submissions for Phase 1 Trials: IND, CTA, and Ethics Review Regulatory Submissions for Phase 1 Trials: IND, CTA, and Ethics Review Introduction Before a Phase 1 clinical trial can begin, sponsors must receive regulatory authorization and ethics approval. The requirements vary by country, but the fundamental goal is the same: to ensure that human…
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Introduction to Phase 0 Trials: Objectives, Design, and Rationale Understanding Phase 0 Trials: Purpose, Design, and Why They Matter What are Phase 0 Clinical Trials? Phase 0 trials, also known as microdosing studies, are the earliest phase of human clinical research. Introduced as part of an exploratory IND (Investigational New Drug) framework by the U.S….
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Types of Phase 2 Trials: Phase 2A vs. Phase 2B Breaking Down Phase 2A and Phase 2B Clinical Trials: Differences, Design, and Goals Introduction Phase 2 clinical trials serve a dual purpose—exploring efficacy and optimizing dose—before a treatment enters large-scale confirmatory trials. To better structure these goals, Phase 2 is often divided into two subphases:…
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Designing a Phase 1 Protocol: Elements, Strategy, and Best Practices Designing a Phase 1 Protocol: Elements, Strategy, and Best Practices Introduction The protocol is the cornerstone of every clinical trial. In Phase 1 studies—often first-in-human (FIH)—it becomes even more critical due to the exploratory nature, safety risks, and regulatory scrutiny. A well-designed protocol ensures scientific…
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Objectives of Phase 2 Studies: Safety, Efficacy, and Dose Refinement Understanding the Core Objectives of Phase 2 Clinical Trials Introduction Phase 2 clinical trials serve as a critical checkpoint in the drug development process. After a drug demonstrates basic safety in Phase 1, it enters Phase 2 to begin evaluating whether it works in a…
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Key Differences Between Phase 0 and Phase 1 Trials Key Differences Between Phase 0 and Phase 1 Clinical Trials Introduction Both Phase 0 and Phase 1 trials are part of early-phase clinical research, but they serve distinct purposes in drug development. Understanding their differences is critical for planning development strategies, regulatory submissions, and timelines. This…
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Key Differences Between Phase 1 and Phase 2 Trials Comparing Phase 1 and Phase 2 Clinical Trials: Objectives, Design, and Execution Introduction Clinical trials are conducted in distinct phases, each with a specific purpose and methodology. Among these, Phase 1 and Phase 2 trials represent the critical early stages of human testing. Although they are…
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