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