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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

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...
Preclinical Development: Overview01:28

Preclinical Development: Overview

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...
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
Clinical Trials01:16

Clinical Trials

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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Related Experiment Video

Updated: May 13, 2026

MRI-guided Focused Ultrasound Thalamotomy for Patients with Medically-refractory Essential Tremor
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Published on: December 13, 2017

Methodological issues in clinical drug development for essential tremor.

Michael A Carranza1, Madeline R Snyder, Rodger J Elble

  • 1Department of Neurology, University of South Florida, Tampa, Florida, United States of America.

Tremor and Other Hyperkinetic Movements (New York, N.Y.)
|February 27, 2013
PubMed
Summary

Essential tremor (ET) is a common neurological disorder. Current treatments are insufficient for many patients, highlighting the need for improved drug development strategies for essential tremor.

Keywords:
Essential tremoretiologymethodologytremor

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Area of Science:

  • Neurology
  • Clinical Pharmacology

Background:

  • Essential tremor (ET) is a prevalent neurological condition.
  • Current treatments, primidone and propranolol, have Level A recommendations but are ineffective for up to 50% of patients.
  • There is a significant unmet need for novel therapeutic agents for ET.

Purpose of the Study:

  • To review methodological challenges in clinical drug development for essential tremor.
  • To identify areas for improvement in designing clinical trials for ET.

Main Methods:

  • This is a review article, synthesizing existing literature and expert opinion.
  • Discussion focuses on critical aspects of clinical trial design, including patient selection, outcome measures, and study endpoints.

Main Results:

  • Identified key methodological issues in current ET drug development.
  • Highlighted the need for standardized and robust clinical trial methodologies.

Conclusions:

  • Addressing methodological flaws is crucial for advancing ET pharmacotherapy.
  • Improved clinical trial design will facilitate the development of more effective treatments for essential tremor.