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Definition
| 1906 Standards of drug purity, not drug safety |
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Term
Federal Food, Drug, And Cosmetic Act
FDA |
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Definition
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Term
| Durham-Humphrey Amendment |
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Definition
| 1952 required prescriptions |
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Term
| Kefauver-Harris Amendment |
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Definition
1962 Thalidomide
Proof of effectivness, safety, animal research, labeling of drugs |
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Term
| Controlled Substances Act |
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Definition
1970 regulated addictive potential drugs
established schedules of drugs
regulated by DEA Drug enforcment agency |
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Definition
morphine
meperidine/demerol |
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Definition
| 1970 Child proof containers |
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Definition
1984 generics of brand w/o additional testing
data submitted as ANDA |
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Definition
| 1997 allow faster review of drugs that may be useful in life threatening disease |
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Term
| Drug Safety Oversight Board |
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Definition
2005 resulted from Vioxx problems
monitor potential adverse reports for a drug after marketed |
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Term
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Definition
Drug Evaluation
Biologics Evaluation
Food Safety
Devices
Veterinary Medicine
Toxicology |
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Term
Phases of Drug Development
1 |
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Definition
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Term
Phases of Drug Development
2 |
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Definition
| Safety evaluation (animals and humans) |
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Term
Phases of Drug Development
3 |
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Definition
| Effectivness evaluation (humans) |
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Term
Phases of Drug Development
4 |
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Definition
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Term
Phases of Drug Development
5 |
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Definition
| Post-Marketing surveillance |
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Definition
| submitted if impressive margin of safety in mice, if approved can begin human testing |
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Term
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Definition
begins after IND approval
establishes effects of predetermined dose and toxicity dose |
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Definition
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Definition
verify drug efficacy
initiated after effective dose range established |
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Term
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Definition
submitted after 8 years of testing
5ft high papers
if approved can sell drug for 17 years from date of phase I clinical testing |
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Term
Post Marketing Surveillance
Phase 4 |
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Definition
After FDA aprroval
collect data to define side effects |
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Definition
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drug wont dissolve
shake well |
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Definition
oil
emulsifier
external prep |
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Definition
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Definition
| sweetened water alcohol solution |
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Definition
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Definition
| clinically desirable action |
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Definition
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Definition
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Term
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Definition
| undesired tolerable effect |
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Term
| First pass effect/metabolism |
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Definition
| significant portion of drug metabolized into inactive products prior to entering systemic circulation |
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Definition
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Definition
FDA
usually shortened chemical name |
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Term
| local anesthetic/ vasoconstrictor precautions |
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Definition
| Specific info to prevent potential drug interactions related to anesthesia |
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Term
| Effects on Dental Treatment |
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Definition
| Significant side effects of drug therapy which my directly or indirectly affect dental treatment or diagnosis |
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Definition
| How the drug works in the body to elicit a response |
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Definition
| info pertaining to inappropriate use of drug as dictated by the approved labeling |
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Definition
| Precautionary considerations, hazaurdous conditions related to use of drug, and disease states or patient population in which drug should be cautiously used |
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Term
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Definition
| Approved labeling by FDA based on accepted clinical evaluation on safety and efficacy of the drug submitted in the NDA. FDA considers new drug "safe and effective" |
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Term
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Definition
| When a drug has an established use specific to dentistry and/or oral medicine |
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Term
Drug Hypersensitivities
Type I |
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Definition
IgE
Asthma, anaphylaxis, dermatitis |
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Definition
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Term
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Definition
1. Name, address of patient, date
2. Rx
3. Name of medicine, dose form, strength
4. Directions to Pharmacist
5. Directions to patient "sig"
6. prescribers signature
7. Refill info |
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Term
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Definition
| Human Studies no fetal risk |
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Definition
| Animal studies no fetal risk |
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Definition
| Animal fetal risk, no human data |
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Definition
| Human risk, benefits acceptable |
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Term
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Definition
Animal/Human abnormalities
Contraindicated in pregnant/may become pregnant women |
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