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Suggested Citation:"Appendix C: Glossary." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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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.

Suggested Citation:"Appendix C: Glossary." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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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.

Suggested Citation:"Appendix C: Glossary." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
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Page 143
Suggested Citation:"Appendix C: Glossary." Institute of Medicine. 1997. Halcion: An Independent Assessment of Safety and Efficacy Data. Washington, DC: The National Academies Press. doi: 10.17226/5940.
×
Page 144
Next: Appendix D: Acronyms »
Halcion: An Independent Assessment of Safety and Efficacy Data Get This Book
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Regulatory agencies within the United States and the United Kingdom, among several other countries, have reviewed extensively the safety and efficacy of Halcion (triazolam)--a once commonly used hypnotic drug. Concerns began to emerge about the safety of Halcion when a Dutch physician reported a possible link between it and a syndrome that included such effects as depression, amnesia, hallucinations, and increased anxiety. In addition, in 1991 its manufacturer, Upjohn, noted that "errors had been identified in a report of one of the clinical studies included in the original" application for approval. Since then, the drug has been removed from the market in several countries, whereas in the United States and Canada, the drug's labeling has been modified to reduce the recommended dose and duration of treatment and to heighten awareness of possible side effects. Yet different data and analyses have resulted in conflicting messages that are difficult to reconcile and interpret. In response to a request from the Food and Drug Administration to resolve these controversial issues related to the safety and efficacy of Halcion, this IOM book assesses the adequacy of the drug's clinical trials; the quality and quantity of data on adverse reactions; overall confidence in the data on effectiveness, adverse events, and side effects at different doses; and whether additional studies are needed.

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