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Related Concept Videos

Survey Safety01:28

Survey Safety

Surveying near highways, rough terrain, or power lines involves significant risks. Working along highways is particularly dangerous and requires the use of warning signs and flagmen. It is safest to avoid working directly on roads and use offsets whenever possible. When highway work is unavoidable, it must follow all safety guidelines. Surveyors should wear bright clothing, such as orange reflective vests, to ensure visibility to motorists, coworkers, and hunters. In construction zones, wearing...
Hazard Analysis and Critical Control Points (HACCP)01:30

Hazard Analysis and Critical Control Points (HACCP)

Hazard Analysis and Critical Control Points (HACCP) is a science-based, preventive system used globally to ensure food safety by identifying, evaluating, and controlling biological, chemical, and physical hazards throughout food production. Originally developed by NASA and the Pillsbury Company for astronaut food, HACCP is now a core component of the Codex Alimentarius.HACCP operates on prerequisite programs—such as Good Manufacturing Practices (GMPs), sanitation procedures, and supplier...
Design Consideration01:22

Design Consideration

Designing a structure involves a series of considerations, primarily the material's ultimate strength, calculated through tests that measure changes under increased force until the material reaches its breaking point or limit. The ultimate load, where the material breaks, is divided by its original cross-sectional area, resulting in the ultimate normal stress or strength. The ultimate shearing stress is another significant factor taken into account.
The factor of safety is another key aspect...
Design Example: Analyzing Capacity Contours for Flood Risk Assessment01:17

Design Example: Analyzing Capacity Contours for Flood Risk Assessment

Flood risk assessment involves careful planning and analysis to ensure the safety of communities near water retention structures. Capacity contours are a vital tool in this process, as they illustrate the potential spread of water at specific levels in a given area. In the context of building a bund across a small valley, these contours play a critical role in evaluating the safety of nearby residential areas.In this example, the bund is intended to store stormwater in the valley. The engineers...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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, controlled...
Hazard Rate01:11

Hazard Rate

The hazard rate, also known as the hazard function or failure rate, is a statistical measure used to describe the instantaneous rate at which an event occurs, given that the event has not yet happened. From a probabilistic perspective, it represents the likelihood that a subject will experience the event in a very small time interval, conditional on surviving up to the beginning of that interval. In terms of frequency, the hazard rate can be viewed as the ratio of the number of events to the...

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Related Experiment Video

Updated: Jul 6, 2026

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

Developing tools for the safety specification in risk management plans: lessons learned from a pilot project.

Andrew J P Cooper1, Sally Lettis, Charlotte L Chapman

  • 1GlaxoSmithKline (GSK) Ltd, Greenford, Middlesex, UK. andrew.j.cooper@gsk.com

Pharmacoepidemiology and Drug Safety
|April 3, 2008
PubMed
Summary

New methods for presenting clinical safety data were identified, improving risk management plans (RMP) for marketing authorisation applications (MAA). These evidence-based tools enhance the analysis and presentation of drug safety information.

Related Experiment Videos

Last Updated: Jul 6, 2026

An R-Based Landscape Validation of a Competing Risk Model
05:37

An R-Based Landscape Validation of a Competing Risk Model

Published on: September 16, 2022

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Clinical Trial Data Analysis
  • Regulatory Science

Background:

  • Marketing Authorisation Applications (MAA) now require Risk Management Plans (RMP) per ICH E2E guidelines.
  • RMPs must detail cumulative safety experience and identify data limitations.
  • A collaborative project aimed to explore tools for safety data presentation and evaluation.

Purpose of the Study:

  • To gain experience with tools for presenting and evaluating data within the safety specification of RMPs.
  • To identify useful tools and document lessons learned from their application.
  • To advance methods for analyzing and presenting clinical safety data.

Main Methods:

  • Utilized archived data from a successful MAA.
  • Assessed methods for demonstrating clinical safety experience extent.
  • Evaluated sensitivity of clinical trial data to detect treatment differences.
  • Identified safety signals from adverse event and laboratory data.

Main Results:

  • Patient exposure over time was visualized using plots.
  • Adverse event data were presented with dot plots, including percentages, odds ratios, and confidence intervals.
  • Power and confidence interval plots assessed clinical database sensitivity.
  • Box and whisker plots were used for laboratory data visualization.

Conclusions:

  • Identified new evidence-based methods for presenting and evaluating clinical safety data.
  • These methods represent an advancement in analyzing and presenting safety data from clinical trials.
  • Emphasized the importance of early, comprehensive safety package planning, including epidemiology data.