deck_5888341 Flashcards
What type of drug class contains the syllable:-olol
β2-adrenergic blocker, antihypertensive and/or antianginal
What type of drug class contains the syllable:-alol, -ilol
Combination alpha/beta blocker, antihypertensive, heart failure treatment
What type of drug class contains the syllable:-terol
β2-adrenergic receptor type of bronchodilator
What type of drug class contains the syllable:-zosin, -osin
α1-adrenoceptor selective antagonists, antihypertensive;
What type of drug class contains the syllable:-curium, -curine, -curarine
Isoquinoline neuromuscular blocking agents
What type of drug class contains the syllable:-curonium
Steroid derivative neuromuscular blocking agents
What type of drug class contains the syllable:-choline
Cholinesterase sensitive choline ester cholinergic agonists
What type of drug class contains the syllable:-chol
Cholinesterase resistant choline ester cholinergic receptor agonists`
What type of drug class contains the syllable:-stigmine
Carbamate anticholinesterase inhibitors
What are the 3 main Characteristics of an Ideal drug and the other 3 important characteristics (total 6)
Effective (main) Safe(main) Selective(main) Reversible Predictable Inexpensive
What is the goal of phase I in moving from IND to NDA
– Determine safe and tolerated doses– Establish pharmacokinetics
What is the goal of phase II in moving from IND to NDA
– Efficacy in proper patients– Small scale study in selected environments
What is the goal of phase III in moving from IND to NDA
– Large scale multi-center clinical trials– Double blind crossover studies– Tested against Standard of Care– Submission of NDA
What is the goal of phase IV in drug development
– Postmarketing surveillance
Placebo
Which Regulatory act:Prevented mislabeling and adulteration and created the FDA
Pure Food and Drug Act (1906)
Which Regulatory act:Prevented false advertising
Amendment to Pure Food and Drug Act (1912)
Which Regulatory act:Declared safety and purity based upon USP and NF criteria enforced by FDA
Food, Drug and Cosmetic Act (1938)
Which Regulatory act:Said theFDA was permitted to determine OTCs
Durham-Humphrey Amendment (1952)
Which Regulatory act:Stated their needed to be proof of efficacy and safety
Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act (1962)
What are the 5 categories of safety in Pregancy and what do they mean with regard to the drug and pregnancy?What are the new Pregnancy categories from the FDA and by what law?
•Category A: No risk to fetus•Category B: Risk observed in animals•Category C: Adverse effects in animals•Category D: Possible human fetal risk•Category X: Known fetal abnormalitiesPregnancy (fetal risk summary),Lactation, and Female and male reproductive potential (ifo about contraception infertility and need forpreg testing)Under Pregnancy and lactation labeling rule
Which Regulatory Act:Gave incentives for drugs targeting diseases affecting <200K in US (e.g. Huntington’s disease, Tourettes, ALS, Muscular Dystrophy)
Orphan Drug Amendment (1983)
Which Regulatory Act:Abbreviated generic applications, required bioequivalence and extended patent life
Drug Price Competition and Patent Restoration Act (1984)Abbreviated generic applications (ANDAs), required bioequivalence and extended patent life (Hatch-Waxman Act)
Which Regulatory Act:Mademanufacturers pay user fees for certain applications. Also accelerated approval for drugs of high medical need
Prescription Drug User Fee (1992, reauthorized 2007, 2012)
