Marketed drugs - Guides d'étude, Notes de cours & Résumés

Alabama MPJE Questions and Answers Already Passed Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey A...

North Carolina MPJE Questions and Answers Rated A+ Pure Food and Drug Act of 1906 prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938 Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951 Established two classes of medications: Rx and ...

Pure Food and Drug Act of 1906Answer - prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938Answer - Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951Answer - Established two classes of medications: Rx and OTC. Authorized oral prescriptions...

1906 Pure Food and Drug Act - Answer Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs. Prohibits the mislabeling and misbranding of products. 1938 Food, Drug and Cosmetic Act (FDCA) - Answer This act requires that manufacture prove a new drug is safe for human consumption. Toxicological studies - done on animals. Clinical trials - done on humans. Gave rise to the Food and Drug Administration. Manufacturer must submit New Drug Application (NDA) to...

Rau's Respiratory Care Pharmacology Ch. 1 with Complete Solutions Respiratory Care Pharmacology Application of pharmacology to the treatment of pulmonary disorders and, more broadly, critical care. Pharmacology the study of drugs, including their origins, properties, and interactions with living organisms Pharmacokinetics Time course and disposition of a drug in the body, based on its absorption, distribution, metabolism, and elimination. Pharmacodynamics The mechanism of drug a...

Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills

NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbranding Pure Food and Drug Act (1906) description -mandated accurate p...

Rank speed of absorption: Po, IM, IV - Answer-Po slowest, then IM, IV fastest Describe drug distribution in relation to protein binding - Answer-Protein binding- Most drugs form a compound and bind with plasma proteins. Drug molecules bound to plasma proteins are pharmacologically inactive. Only the free or unbound portions of the drug acts on the cells. Protein binding allows for some of the drug to be stored and others to be released as needed. This gives the constant blood level and decr...

A woman has been prescribed paroxetine hydrochloride, which is an antidepressant agent administered in pill form. The medication is administered for her obsessivecompulsive disorder. This medication will produce which of the following effects? A) Curative B) Systemic C) Local D) Parenteral Ans: B Feedback: Drugs that produce systemic effects are taken into the body, circulated through the bloodstream to their sites of action in various body tissues, and eventually eliminated from ...

Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Not required to have directions for ...