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Related Concept Videos

Clinical Trials01:16

Clinical Trials

6.9K
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...
6.9K
Clinical Trials: Overview01:11

Clinical Trials: Overview

3.0K
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...
3.0K
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.5K
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...
4.5K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

540
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
540
Therapeutic Index01:13

Therapeutic Index

4.4K
The therapeutic index of a drug is a key parameter in pharmacology that quantifies the relative safety of a drug by calculating the ratio between the dose that causes toxicity in half the population (50%) to the dose that proves to be effective for half the population (50%). It provides a spectrum of doses for a particular drug ranging from effective to potentially toxic. To illustrate, consider an anticoagulant agent like warfarin. It possesses a narrow window within its therapeutic index to...
4.4K
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

148
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.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
148

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Updated: Jul 20, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
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Clinical therapeutic trials.

W Watson Buchanan1, Colin A Kean2, K D Rainsford3

  • 1Department of Medicine, McMaster University, Hamilton, ON, L8P 1H6, Canada.

Inflammopharmacology
|August 3, 2023
PubMed
Summary
This summary is machine-generated.

Clinical trials investigate therapeutic interventions for efficacy and safety. Early examples date back to ancient Babylon, with documented trials emerging over the last 500 years, leading to modern ethical standards.

Keywords:
Clinical trialsEpidemiologyEthicsMedicinal agentsStatisticsTherapeutics

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Area of Science:

  • Medical Research
  • History of Medicine
  • Clinical Pharmacology

Background:

  • Clinical trials are essential for evaluating new treatments and understanding potential side effects.
  • Historical records suggest early forms of clinical investigation in ancient civilizations.
  • Systematic documentation of therapeutic interventions has evolved significantly over the past five centuries.

Purpose of the Study:

  • To define the concept and historical evolution of clinical trials.
  • To highlight key historical examples that shaped modern clinical trial practices.
  • To underscore the importance of ethical considerations and scientific rigor in therapeutic research.

Main Methods:

  • Historical analysis of medical practices and documentation.
  • Review of significant early medical experiments and their outcomes.
  • Examination of the development of ethical guidelines and scientific standards in medicine.

Main Results:

  • Clinical trials aim to establish treatment benefits and identify toxicity.
  • Notable historical examples include Lind's scurvy study and Jenner's smallpox inoculation.
  • The evolution of clinical trials is marked by increasing emphasis on human ethics, observation, and statistical analysis.

Conclusions:

  • Modern clinical trials are built upon a foundation of historical experimentation and ethical development.
  • Rigorous methodology, including statistical analysis and safety testing, is crucial for valid clinical trial outcomes.
  • The progression of clinical trials reflects a continuous effort to ensure therapeutic interventions are both safe and effective.