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Appendix D: Glossary
Pages 279-284

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From page 279...
... Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure and function of the body of humans or other animals. Elements of a drug that are not API are called inert pharmaceutical ingredients.1,2 Acute pain: A complex, unpleasant emotional, cognitive, and sensory experience that is usually correspondent with the degree of tissue damage and that lessens as the injury heals.
From page 280...
... Bulk drug substance: Any substance that is intended for incorporation into a finished drug product or preparation and is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body, but the term does not include intermediates used in the synthesis of such substances.5 Cancer pain: Can be caused by the cancer itself or by the surgery, treatments, or tests used to diagnose and treat cancer. The amount and duration of pain varies, depending on the source.
From page 281...
... Chronic regional pain syndrome: A chronic pain condition that most often affects one limb, usually after injury, and is characterized by prolonged or excessive pain and changes in skin color, temperature, and/or swelling. Clinical trial: Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.
From page 282...
... When evaluations with such experimental designs are not available, evidence for efficacy or effectiveness cannot be considered definitive. Excipient: A pharmacologically inactive ingredient used in the formulation of a drug that lends various functional properties to the drug formulation (i.e., dosage form, drug release, etc.)
From page 283...
... Pain: An unpleasant sensory and emotional experience associated with subjective perception and interpretation of actual or potential tissue damage, or stimuli described in terms of such damage. There are many medically recognized qualifiers to pain including acute, chronic, myofascial, musculo­ skeletal, neuropathic, and high impact.8 Paste: A stiff semisolid dosage form that contains finely powdered solids.
From page 284...
... -approved drug product: The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients, and has received FDA approval for safety and effectiveness. An FDA-approved drug product will appear in FDA's Orange Book.


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