Tag: clinical trial phase analysis

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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Selecting the Right Candidates for Phase 0: Drug Selection Criteria How to Choose the Right Drug Candidates for Phase 0 Clinical Trials Why Drug Selection Matters in Phase 0 Trials Not every drug candidate is suitable for a Phase 0 microdosing study. These trials are designed to generate early pharmacokinetic (PK) and pharmacodynamic (PD) data…

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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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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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GLP Compliance in Preclinical Research Laboratories Ensuring GLP Compliance in Preclinical Research Laboratories What is Good Laboratory Practice (GLP)? Good Laboratory Practice (GLP) is a quality system concerned with the organizational processes and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. It ensures the reliability and…

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Ethical Considerations in Preclinical Animal Testing Ensuring Ethics in Animal Testing During Preclinical Research Why Ethics Matter in Preclinical Animal Testing Animal studies are essential for evaluating the safety and efficacy of new drugs before human trials. However, their use comes with significant ethical responsibility. Animals are sentient beings, and using them in research must…

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Translational Science: Bridging Preclinical and Clinical Research How Translational Science Connects Preclinical Research to Clinical Practice What is Translational Science? Translational science refers to the process of turning laboratory discoveries and preclinical findings into therapeutic interventions that can be tested and used in humans. It forms the critical bridge between basic science and clinical application,…

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Preclinical Study Design Best Practices A Guide to Best Practices in Designing Preclinical Studies Introduction: Why Study Design Matters in Preclinical Research The quality of a preclinical study depends heavily on its design. A well-structured study can offer reliable, reproducible, and regulatory-acceptable data that supports the transition of a drug into human trials. Poorly designed…

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ADME Studies: Understanding Drug Behavior Before Clinical Trials Exploring ADME Studies: How Drugs Behave Before Clinical Trials Begin What Are ADME Studies in Preclinical Research? ADME stands for Absorption, Distribution, Metabolism, and Excretion—a core set of pharmacokinetic processes that describe what the body does to a drug. Understanding these parameters is essential before any new…

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