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Related Concept Videos

Clinical Trials01:16

Clinical Trials

6.6K
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...
6.6K
Clinical Trials: Overview01:11

Clinical Trials: Overview

2.4K
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...
2.4K
Drug Regulation01:25

Drug Regulation

1.2K
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...
1.2K
Pharmacovigilance01:19

Pharmacovigilance

735
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
735
Preclinical Development: Overview01:28

Preclinical Development: Overview

4.0K
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...
4.0K
Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

377
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...
377

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Related Experiment Video

Updated: Jun 13, 2026

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

Published on: December 11, 2016

US Food and Drug Administration's Advancing Real-World Evidence Program: Initial Experience.

Kimberly A Smith1, Yin Huang2, Theresa Kehoe1

  • 1Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Clinical Pharmacology and Therapeutics
|April 27, 2025
PubMed
Summary
This summary is machine-generated.

Real-world data (RWD) and real-world evidence (RWE) are increasingly used to support regulatory decisions. The US Food and Drug Administration (FDA) established the Advancing RWE Program to foster collaboration and build confidence in RWE approaches.

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Comprehensive Analysis of Drug Response using the FLICK Assay
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Related Experiment Videos

Last Updated: Jun 13, 2026

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

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Published on: December 11, 2016

Feeding Experimentation Device (FED): Construction and Validation of an Open-source Device for Measuring Food Intake in Rodents
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Comprehensive Analysis of Drug Response using the FLICK Assay
09:42

Comprehensive Analysis of Drug Response using the FLICK Assay

Published on: June 6, 2025

Area of Science:

  • Regulatory Science
  • Health Informatics
  • Data Science

Background:

  • Real-world data (RWD) availability and analysis have advanced significantly.
  • Robust real-world evidence (RWE) can now be generated to support regulatory decision-making.
  • Cross-discipline collaboration is crucial for maximizing RWE's potential in regulatory settings.

Purpose of the Study:

  • To address the need for increased confidence in RWE-based regulatory approaches.
  • To establish a new pathway for regulatory interactions concerning RWE.
  • To foster expertise and collaboration in the use of RWE for regulatory purposes.

Main Methods:

  • Leveraging advances in RWD availability and analytical methodologies.
  • Implementing collaborative, cross-discipline approaches.
  • Establishing the FDA's Advancing RWE Program for regulatory interactions.

Main Results:

  • Increased generation of robust RWE.
  • Enhanced confidence in RWE-based regulatory submissions.
  • A new FDA program facilitating RWE discussions.

Conclusions:

  • The Advancing RWE Program provides a vital platform for regulatory engagement on RWE.
  • Cross-discipline collaboration is key to realizing the full potential of RWE in regulatory science.
  • Continued development of RWE methodologies will further support regulatory decision-making.