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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Clinical Trials01:16

Clinical Trials

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Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Study Designs in Epidemiology01:20

Study Designs in Epidemiology

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Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
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Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs01:15

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Body:Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...
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Related Experiment Video

Updated: Feb 16, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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New study designs in clinical drug development.

Olli Tenhunen, Miia Turpeinen, Pekka Kurki

    Duodecim; Laaketieteellinen Aikakauskirja
    |December 16, 2017
    PubMed
    Summary

    Clinical drug development is evolving beyond traditional four-phase trials. New approaches leverage individualized medicine and target-oriented strategies for more precise drug testing and development.

    Area of Science:

    • Pharmacology and Clinical Trials
    • Drug Development and Regulatory Science

    Background:

    • Traditional drug development follows a four-phase model to assess efficacy and safety.
    • Evolving trends in individualized medicine and drug mechanisms are impacting clinical trial designs.

    Purpose of the Study:

    • To explore the shifts in clinical drug development paradigms.
    • To highlight the move towards more personalized and targeted drug testing strategies.

    Main Methods:

    • Analysis of current trends in clinical trial design.
    • Examination of the integration of individualized medicine and target-oriented development.
    • Review of the increasing use of registry data and modeling.

    Main Results:

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  • Clinical development phases are becoming less distinct.
  • Traditional large-scale studies may be supplemented by individual and risk-based approaches.
  • Target-oriented drug development and data utilization are increasing.

    • Conclusions:

    • Clinical drug development is adapting to personalized medicine and novel drug actions.
    • Future drug testing will likely involve more flexible, data-driven, and targeted methodologies.