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Appendix C: Glossary
Pages 247-252

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From page 247...
... 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 an API are called inert pharmaceutical ingredients.1,2 adverse event: An adverse event is any undesirable experience associated with the use of a medical product or preparation in a patient.2 andropause: Also termed "late-onset hypogonadism," "testosterone deficiency syndrome," and colloquially, "male menopause," is a decrease in androgens, especially testosterone, in males that is associated with aging.
From page 248...
... -approved products, or products that have not undergone FDA approval. 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.2 clinical need: When used in this report, "clinical need" refers to the condition outlined by Congress in Section 503B of the Federal Food, Drug, and Cosmetic Act as amended by the Drug Quality and Security Act of 2013 that prohibits 503B outsourcing facilities from compounding with a bulk drug substance unless the substance appears on a list established by the U.S.
From page 249...
... Food and Drug Administration approved.2 compounding pharmacy: A pharmacy that makes compounded preparations in response to or anticipation of a prescription order for an individual patient. conventional hormone therapy: In regard to hormone therapy, conventional refers to U.S.
From page 250...
... evidence-based medicine: To the greatest extent possible, the decisions that shape the health and health care of Americans -- by patients, providers, payers, and policy makers alike -- will be grounded on a reliable evidence base, will account appropriately for individual variation in patient needs, and will support the generation of new insights on clinical effectiveness. 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 251...
... natural: Describes a hormone drug product derived from a naturally occurring steroid that requires no chemical modification for human administration. night sweats: Recurring episodes of intense perspiration during sleep, irrelevant of ambient temperature.
From page 252...
... Progestogens include progesterone and progestins. semisynthetic: Describes a hormone derived from a naturally ocurring steroid or sterol that requires chemical synthesis for human administration (e.g., hormones derived from soy and Mexican yams)


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