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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...
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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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Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Drug Discovery: Overview01:26

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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

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Published on: December 11, 2016

Global aspects of drug development.

Kalle Hoppu1, Hans V Hogerzeil

  • 1Poison Information Centre, Helsinki University Central Hospital and Hospital for Children and Adolescents, Institute for Clinical Sciences, University of Helsinki, Helsinki, Finland. kalle.hoppu@hus.fi

Handbook of Experimental Pharmacology
|September 2, 2011
PubMed
Summary

Millions of children under five die annually from treatable conditions. Improving access to essential medicines for children globally is crucial for achieving child health goals and addressing developmental needs.

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Area of Science:

  • Child Health
  • Global Health
  • Pharmaceutical Development

Background:

  • Approximately nine million children under five die yearly from preventable or treatable conditions.
  • Lack of access to appropriate medicines is a significant, though not the sole, contributor to child mortality.
  • Existing medicines could prevent many of these deaths, highlighting a critical gap in healthcare access.

Purpose of the Study:

  • To explore the challenges and opportunities in developing pediatric medicines for the developing world.
  • To emphasize the importance of global and regional initiatives in pediatric medicine development.
  • To highlight tools and strategies for improving children's access to essential medicines.

Main Methods:

  • Review of global child mortality data related to treatable conditions.
  • Analysis of the role of existing medicines in pediatric healthcare.
  • Examination of regional and global initiatives for pediatric medicine development.
  • Case study of the World Health Organization's Essential Medicines List for children.

Main Results:

  • Many childhood deaths are preventable with existing, accessible medicines.
  • Global and regional collaborations can amplify the impact of pediatric medicine initiatives.
  • The Essential Medicines List for children is a key tool for improving access.

Conclusions:

  • Enhanced access to appropriate medicines is vital for achieving global child health targets.
  • Targeted development and distribution of pediatric medicines are essential for low-resource settings.
  • International cooperation and resource allocation are critical for pediatric pharmaceutical advancement.