Halcion An Independent Assessment of Safety and Efficacy Data (1997) / Chapter Skim
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Appendix C: Glossary
Appendix C: Glossary
Pages 143-144
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From page 143... ...
The phrase related to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, that is, the relationship cannot be ruled out. Benefit/risk ratio The ratio of benefit to risk in the use of a drug; a means of expressing a judgment concerning the role of the drug in the practice of medicine, based on efficacy and safety data along with consideration of misuse potential, severity and prognosis of the disease, etc.
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From page 144... ...
Serious event Any adverse event that is fatal, life-threatening, permanently or significantly disabling, requires or prolongs hospitalization, congenital anomaly, or requires intervention to prevent permanent impairment or damage. Therapeutic equivalence Pharmaceutical products that, when administered to the same individuals in the same regimen, will provide essential the same efficacy and toxicity.
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