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)
Which Regulatory Act:
Amended the 1958 Food Additive Act to regulate dietary supplements as foods. And is the only current legislation regulating herbal medicines and dietary supplements
Dietary Supplement Health and Education Act (1994)
Which Regulatory Act:
Was an extension of PDUFA that extended “fast track” to drugs for diseases other than cancer and AIDS. Permitted drug companies to provide information to prescribers regarding “off-label” uses of drugs
Food and Drug Administration Modernization Act (FDAMA) [1997]
Which Regulatory Act:
Enhanced controls of dangerous biological agents and chemical toxins
Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act (2002)
Which Regulatory Act:
Expanded FDA mission to include rigorous oversight of drug safety after a drug was approved (i.e. increased authority for postmarketing surveillance) and for DTCA (Direct to Consumer Advertising)
FDA Amendments Act (FDAAA) [2007]
Which Regulatory Act:
Established FDA program of abbreviated approval for “biosimilar” products
Biologics Price Competition and Innovation Act (2009)
Which Regulatory Acts:
Were the first legislative efforts to promote research on drug efficacy and safety in children
- Best Pharmaceuticals for Children Act (BPCA) [2002]
- Pediatric Research Equity Act (PREA) [2003]
Which Controlled Substance class would be viewed as:
High abuse potential
Accepted Medical Uses
Class 2/2N
Which Controlled Substance class would be viewed as:
High abuse potential
No Accepted Medical Uses
Schedule 1
(heroin, LSD, Marijuana)
Which Controlled Substance class would be viewed as:
Moderate abuse potential
Accepted Medical Uses
Schedule 3/3N
Which Controlled Substance class would be viewed as:
Lowest abuse potential
Accepted Medical Uses
Schedule 5
(cold remedies with codeine)
Which Controlled Substance class would be viewed as:
Lower abuse potential
Accepted Medical Uses
Schedule IV
(tramadol)
