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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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An experiment is a planned activity carried out under controlled conditions. The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory or independent variable. The affected variable is called the response or dependent variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The...
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In a beam of charged particles created by a heated cathode, the particles move at different speeds. However, many applications need a beam with uniform particle speeds. An arrangement known as a velocity selector uses electric and magnetic fields to pick particles with a particular speed from the beam.
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When conducting an experiment, it is crucial to have control to reduce bias and accurately measure the dependent variables. It also marks the results more reliable. Controls are elements in an experiment that have the same characteristics as the treatment groups but are not affected by the independent variable. By sorting these data into control and experimental conditions, the relationship between the dependent and independent variables can be drawn. A randomized experiment always includes a...
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Randomized Experiments01:13

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The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
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Crossover experiments, also called the repeated-measurements design, is a study design in which all experimental units are exposed to all treatments in different periods. Crossover experiments are generally used in psychology, the pharmaceutical industry, agriculture, and medicine.
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CDEK: Clinical Drug Experience Knowledgebase.

Rebekah H Griesenauer1, Constantino Schillebeeckx1, Michael S Kinch1

  • 1Center for Research Innovation in Biotechnology, Washington University in St. Louis, MO 63110, USA.

Database : the Journal of Biological Databases and Curation
|August 15, 2019
PubMed
Summary

The Clinical Drug Experience Knowledgebase (CDEK) is a novel database of pharmaceutical ingredients and clinical trials. CDEK enhances drug development research by integrating data from ClinicalTrials.gov and other sources.

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Area of Science:

  • Biomedical Informatics
  • Pharmacology
  • Drug Discovery

Background:

  • ClinicalTrials.gov is a primary source for clinical trial information.
  • Existing drug databases may lack comprehensive data on active pharmaceutical ingredients and their associated organizations.
  • There is a need for a unified resource to facilitate drug development research.

Purpose of the Study:

  • To introduce the Clinical Drug Experience Knowledgebase (CDEK), a database and web platform.
  • To consolidate information on active pharmaceutical ingredients, clinical trials, and organizations involved in drug development.
  • To provide a resource for investigating various aspects of drug development.

Main Methods:

  • Curation of active pharmaceutical ingredients, clinical trials, and organizations.
  • Disambiguation of intervention and organization names from ClinicalTrials.gov.
  • Cross-referencing with other prominent drug databases.

Main Results:

  • CDEK contains 22,292 active pharmaceutical ingredients, 127,223 clinical trials, and 24,728 organizations.
  • 43% of active pharmaceutical ingredients in CDEK are unique and not found in other compound-oriented databases.
  • The database integrates data from ClinicalTrials.gov and other sources.

Conclusions:

  • CDEK serves as a valuable resource for drug discovery and development.
  • The knowledgebase supports research in chemo- and bio-informatics, clinical and translational research, and regulatory sciences.
  • CDEK facilitates the identification of drug repurposing opportunities.