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11 Cards in this Set

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  • Back
Active Control
would be considered evidence of effectiveness of a new agent; however, may simply be incapable of allowing any conclusion as to whether or not the test article is having an effect.
Adverse experience (AE)
any experience that suggests a significant hazard, contraindication, side effect, or precaution.
According to the Federal Food, Drug and Cosmetic Act, (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403 (r)(1)(B) and 403 (r)(3) of this title or sections 403 (r)(1)(B) and 403 (r)(5)(D) of this title, is made in accordance with the requirements of section 403 (r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403 (r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
Dose Proportionality
reflects the body’s proportional response to the dosage of investigational product as evidence, i.e., in suppression of serum HBV DNA levels
Bioavailability (BA)
the rate and extent to which an active ingredient, e.g., drug, enters the general blood circulation; this is determined either by measuring the concentration of the drug in body fluids or by measuring the magnitude of the pharmacologic response. (21 CFR 320.1 (a))
Bioequivalance (BE)
having the same biologic effects as the drug to which a medicine is being compared. (21 CFR 320.1 (e))
Biologic mostly protein compounds, examples, interleukin, interferon, monoclonal antibodies, and recombinant DNA technology; includes any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
ability to cause cancer
Common Rule
Common regulation among government agencies; governs federally funded research involving human subjects. (45 CFR 46)
Comparative Control
most Phase 2 studies are randomized trials. One group of patients will receive the experimental drug, while a second, “control” group, will receive a standard treatment or placebo. The study can provide the pharmaceutical company and the FDA comparative information about the relative safety of the new drug and its effectiveness
Covered Entity
An entity (health plan, clearinghouse, or provider) that conducts one or more of the covered transactions (i.e., transmittals in connection with health care claims, health care payment, referral certification and authorization, and first report of injury) is deemed a “covered entity.”
the desired measure of a investigational product’s influence on a disease condition as proven by substantial evidence from adequate and well-controlled investigations (i.e., proof in or by the marketing application) (21 CFR 314.126)