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Related Concept Videos

Drug Discovery: Overview01:26

Drug Discovery: Overview

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...
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...
Drug Regulation01:25

Drug Regulation

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...
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...
Drug Control Governance: Regulatory Bodies and Their Impact01:03

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.
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...

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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The drug development crisis: efficiency and safety.

C Thomas Caskey1

  • 1Brown Foundation Institute of Molecular Medicine for the Prevention of Human Diseases, The University of Texas Health Science Center at Houston, Houston, Texas 77030, USA. C.Thomas.Caskey@uth.tmc.edu

Annual Review of Medicine
|October 25, 2006
PubMed
Summary

New technologies like high-content cell screening and mass spectroscopy can enhance drug development efficiency and safety. These innovative methods aim to overcome challenges such as rising costs and fewer drug approvals.

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Drug Discovery

Background:

  • Drug development faces challenges including decreased approvals, increased costs, and drug withdrawals.
  • Advancements in genetics, chemistry, and protein engineering have not fully addressed these issues.

Purpose of the Study:

  • To highlight technologic methods for improving drug development efficiency.
  • To discuss technologies that enhance drug safety and performance.

Main Methods:

  • High-content cell screening
  • Expression profiling
  • Mass spectroscopy
  • Disease mouse models
  • Post-launch adverse effect screening

Main Results:

  • Implementation of these technologies promises improved drug development performance.
  • These methods can enhance the safety of pharmaceutical products.

Conclusions:

  • Technologic innovations are crucial for overcoming current drug development hurdles.
  • Adoption of advanced screening and modeling techniques can lead to more efficient and safer drug development pipelines.