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OCR for page 143
Halcion: An Independent Assessment of Safety and Efficacy Data C Glossary Adverse event Any untoward medical occurrence in a patient or a subject is a clinical investigation administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not it is related to the medicinal (investigational) product. (See Serious event) Adverse drug reaction In the preapproval clinical experience with a new medicinal product or its new usages, particularly bemuse the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose. 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. The concept may be applied to a single drug or in comparisons between two or more drugs used for the same indication. Bioavailability The rate and extent of absorption of a drug from a dosage form as determined by its concentration-time curve in the systemic circulation or by its excretion in urine.
OCR for page 144
Halcion: An Independent Assessment of Safety and Efficacy Data Compliance Faithful adherence by the patient to the prescriber's instructions. Dosage form The form of the completed pharmaceutical product, for example, a tablet, capsule, elixir, suppository. Drug Any substance in a pharmaceutical product that is used to modify or explore physiological systems or pathological states for the benefit of the recipient. Drug formulation The composition of a dosage form, including the characteristics of its raw materials and the operations required to process it. Drug utilization The marketing, distribution, prescription, and use of drugs in a society, with special emphasis on the resulting medical, social, and economic consequences. Efficacy The ability of a drug to produce the purported effect as determined by scientific methods. Exclusion Criterion A standard or rule for judging the shutting out or disconnection from the main part. Pharmaceutical product A dosage form containing one or more drugs, along with other substances included during the manufacturing process. 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. Tolerance The pharmacological term indicating a waning effect with the continuing use of the same dose of a drug. The ability to endure or be less responsive to a stimulus, especially over a period of continued exposure.
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