Tag: clinical trial phase ethics

Regulatory Expectations for Phase 4 Studies Globally: FDA, EMA, CDSCO, PMDA & More

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Regulatory Expectations for Phase 4 Studies Globally: FDA, EMA, CDSCO, PMDA & More Global Regulatory Requirements for Phase 4 Clinical Trials: A Country-by-Country Guide Why Regulatory Oversight in Phase 4 Is Critical Once a product receives regulatory approval and enters the market, its journey doesn’t end—rather, it transitions into a new phase: post-marketing surveillance, or…

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Phase 4 (Post-Marketing Surveillance)

Key Differences Between Phase 0 and Phase 1 Trials

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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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Phase 1 (Safety and Dosage)

Key Differences Between Phase 1 and Phase 2 Trials

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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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Phase 2 (Efficacy and Side Effects)

Differences Between Phase 3 and Phase 4 Trials: From Controlled Research to Real-World Practice

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Differences Between Phase 3 and Phase 4 Trials: From Controlled Research to Real-World Practice Phase 3 vs Phase 4 Trials: Key Differences Every Researcher Should Know Why Understanding the Differences Matters Clinical trials progress through a structured series of phases, with Phase 3 and Phase 4 being the final and most public-facing stages. While both…

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Phase 4 (Post-Marketing Surveillance)

Introduction to Phase 1 Clinical Trials: Scope, Purpose, and Regulatory Role

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Introduction to Phase 1 Clinical Trials: Scope, Purpose, and Regulatory Role Introduction to Phase 1 Clinical Trials: Scope, Purpose, and Regulatory Role What Are Phase 1 Clinical Trials? Phase 1 clinical trials are the first stage of human testing in the drug development process. Often referred to as first-in-human (FIH) studies, they focus primarily on…

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Phase 1 (Safety and Dosage)

What are Phase 4 (Post-Marketing) Clinical Trials? A Complete Overview for Clinical Researchers

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What are Phase 4 (Post-Marketing) Clinical Trials? A Complete Overview for Clinical Researchers Understanding Phase 4 Clinical Trials: What Happens After Drug Approval What Are Phase 4 Trials and Why Are They Conducted? Phase 4 clinical trials, often referred to as post-marketing studies, are conducted after a drug or therapy has received regulatory approval and…

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Phase 4 (Post-Marketing Surveillance)

Phase 0 vs. First-in-Human Trials: How to Transition Effectively

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Phase 0 vs. First-in-Human Trials: How to Transition Effectively Phase 0 vs. First-in-Human Trials: Transitioning Safely from Microdosing to Therapeutic Dosing Introduction 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…

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Preclinical Studies

Combining Phase 0 with Adaptive Phase 1 Trials: Strategies for Seamless Transition

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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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Preclinical Studies

PET Imaging and Radiolabeling Techniques in Phase 0 Oncology Studies

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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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Preclinical Studies