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Practice of Regulatory Science (Drug Development)
1National Institute of Health Sciences.
Summary
Regulatory science (RS) ensures drug quality, efficacy, and safety throughout their lifecycle. This integrated science combines biomedical and social sciences for comprehensive pharmaceutical assessment.
Area of Science:
- Pharmaceutical Sciences
- Regulatory Science
- Drug Development
Background:
- Regulatory Science (RS) is crucial for pharmaceutical development and lifecycle management.
- Defined by the Pharmaceutical Society of Japan, RS involves predicting, assessing, and judging drug quality, efficacy, and safety.
Purpose of the Study:
- To describe the practice and scope of Regulatory Science in pharmaceutical development.
- To highlight the interdisciplinary nature of RS, integrating various scientific fields.
Main Methods:
- The study defines RS based on educational materials from the Pharmaceutical Society of Japan.
- It outlines the integration of basic and applied biomedical sciences with social sciences.
Main Results:
- RS is defined as the science of predicting, assessing, and judging pharmaceutical quality, efficacy, and safety.
- RS integrates diverse fields including chemistry, biology, pharmacology, toxicology, biostatistics, epidemiology, and clinical trial methodology.
- Social sciences like decision science, risk assessment, and communication science are also integral to RS.
Conclusions:
- Regulatory Science plays a vital role throughout the drug development phase, starting after lead compound optimization.
- RS is essential for governing pharmaceuticals during their entire life cycle management.