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Clinical Trials: Overview01:11

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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

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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.
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Preclinical Development: Overview01:28

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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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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Bioavailability Study Design: Healthy Subjects Versus Patients01:15

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Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
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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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In Silico Clinical Trials for Cardiovascular Disease
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Clinical Trials Corner: September 2017.

Filipe B Rodrigues1,2,3, Edward J Wild1

  • 1Huntington's Disease Centre, University College London, London, UK.

Journal of Huntington'S Disease
|October 3, 2017
PubMed
Summary
This summary is machine-generated.

This review highlights ongoing and completed clinical trials for Huntington's disease, offering insights into key studies like LEGATO-HD and IONIS-HTTRx, as well as Amaryllis and Pride-HD.

Keywords:
Clinical trialsHuntington’s disease

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Area of Science:

  • Neuroscience
  • Genetics
  • Clinical Research

Background:

  • Huntington's disease (HD) is a progressive neurodegenerative disorder.
  • Effective treatments are urgently needed.
  • Clinical trials are essential for developing new therapies.

Purpose of the Study:

  • To provide an overview of the current clinical trial landscape for Huntington's disease.
  • To detail specific ongoing and recently completed trials.

Main Methods:

  • Systematic review of registered and completed clinical trials.
  • In-depth discussion of selected trials, including LEGATO-HD, IONIS-HTTRx, Amaryllis, and Pride-HD.

Main Results:

  • A comprehensive list of ongoing Huntington's disease trials is presented.
  • Key findings and methodologies of LEGATO-HD, IONIS-HTTRx, Amaryllis, and Pride-HD are summarized.

Conclusions:

  • The review offers a snapshot of recent advancements in Huntington's disease clinical research.
  • It serves as a valuable resource for researchers, clinicians, and patients interested in HD therapeutic development.