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Updated: May 31, 2026
07:55
Using SCOPE to Identify Potential Regulatory Motifs in Coregulated Genes
Published on: May 31, 2011
Regulatory science as a bridge between science and society
T Tominaga1, Y Asahina, Y Uyama
1Pharmaceuticals and Medical Devices Agency, Tokyo, Japan. tominagatoshiyoshi@pmda.go.jp
Clinical Pharmacology and Therapeutics
|June 22, 2011
Summary
Regulatory science (RS) is crucial for balancing drug benefits and risks, but its effectiveness depends on user comprehension. Understanding RS is key to improving innovative drug development and regulatory decision-making.
Area of Science:
- Pharmacology
- Regulatory Science
- Drug Development
Background:
- Innovative drug development faces increasing challenges.
- Balancing drug benefits and risks presents regulatory hurdles, exemplified by rosiglitazone.
Purpose of the Study:
- To highlight the critical role of regulatory science (RS) in addressing drug development difficulties.
- To emphasize the necessity of user understanding for RS to achieve its potential.
Main Methods:
- Analysis of regulatory decision-making challenges.
- Review of the impact of regulatory science on drug approval processes.
Main Results:
- The development of novel therapeutics is becoming more complex.
- Effective regulatory decision-making requires a thorough risk-benefit assessment.
Conclusions:
- Regulatory science holds promise for improving drug regulation.
- Successful implementation of RS is contingent upon widespread understanding of its fundamental principles.
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