Lecture 1 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 the FDA 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 abnormalities
Pregnancy (fetal risk summary), Lactation, and Female and male reproductive potential (ifo about contraception infertility and need for preg 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:
Made manufacturers pay user fees for certain applications. Also accelerated approval for drugs of high medical need
Prescription Drug User Fee (1992, reauthorized 2007, 2012)
