Lecture 1

Question 1

What type of drug class contains the syllable:

-olol

Answer 1

β2-adrenergic blocker, antihypertensive and/or antianginal

Question 2

What type of drug class contains the syllable:

-alol, -ilol

Answer 2

Combination alpha/beta blocker, antihypertensive, heart failure treatment

Question 3

What type of drug class contains the syllable:

-terol

Answer 3

β2-adrenergic receptor type of bronchodilator

Question 4

What type of drug class contains the syllable:

-zosin, -osin

Answer 4

α1-adrenoceptor selective antagonists, antihypertensive;

Question 5

What type of drug class contains the syllable:

-curium, -curine, -curarine

Answer 5

Isoquinoline neuromuscular blocking agents

Question 6

What type of drug class contains the syllable:

-curonium

Answer 6

Steroid derivative neuromuscular blocking agents

Question 7

What type of drug class contains the syllable:

-choline

Answer 7

Cholinesterase sensitive choline ester cholinergic agonists

Question 8

What type of drug class contains the syllable:

-chol

Answer 8

Cholinesterase resistant choline ester cholinergic receptor agonists`

Question 9

What type of drug class contains the syllable:

-stigmine

Answer 9

Carbamate anticholinesterase inhibitors

Question 10

What are the 3 main Characteristics of an Ideal drug and the other 3 important characteristics (total 6)

Answer 10

1. Effective (main)
2. Safe (main)
3. Selective (main)
4. Reversible
5. Predictable
6. Inexpensive

Question 11

What is the goal of phase I in moving from IND to NDA

Answer 11

– Determine safe and tolerated doses

– Establish pharmacokinetics

Question 12

What is the goal of phase II in moving from IND to NDA

Answer 12

– Efficacy in proper patients

– Small scale study in selected environments

Question 13

What is the goal of phase III in moving from IND to NDA

Answer 13

– Large scale multi-center clinical trials

– Double blind crossover studies

– Tested against Standard of Care

– Submission of NDA

Question 14

What is the goal of phase IV in drug development

Answer 14

– Postmarketing surveillance

Question 15

Placebo

Question 16

Which Regulatory act:

Prevented mislabeling and adulteration and created the FDA

Answer 16

Pure Food and Drug Act (1906)

Question 17

Which Regulatory act:

Prevented false advertising

Answer 17

Amendment to Pure Food and Drug Act (1912)

Question 18

Which Regulatory act:

Declared safety and purity based upon USP and NF criteria enforced by FDA

Answer 18

Food, Drug and Cosmetic Act (1938)

Question 19

Which Regulatory act:

Said the FDA was permitted to determine OTCs

Answer 19

Durham-Humphrey Amendment (1952)

Question 20

Which Regulatory act:

Stated their needed to be proof of efficacy and safety

Answer 20

Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act (1962)

Question 21

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?

Answer 21

• 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

Question 22

Which Regulatory Act:

Gave incentives for drugs targeting diseases affecting <200K in US (e.g. Huntington’s disease, Tourettes, ALS, Muscular Dystrophy)

Answer 22

Orphan Drug Amendment (1983)

Question 23

Which Regulatory Act:

Abbreviated generic applications, required bioequivalence and extended patent life

Answer 23

Drug Price Competition and Patent Restoration Act (1984)

Abbreviated generic applications (ANDAs), required bioequivalence and extended patent life (Hatch-Waxman Act)

Question 24

Which Regulatory Act:

Made manufacturers pay user fees for certain applications. Also accelerated approval for drugs of high medical need

Answer 24

Prescription Drug User Fee (1992, reauthorized 2007, 2012)

Question 25

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

Answer 25

Dietary Supplement Health and Education Act (1994)

Question 26

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

Answer 26

Food and Drug Administration Modernization Act (FDAMA) [1997]

Question 27

Which Regulatory Act:

Enhanced controls of dangerous biological agents and chemical toxins

Answer 27

Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act (2002)

Question 28

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)

Answer 28

FDA Amendments Act (FDAAA) [2007]

Question 29

Which Regulatory Act:

Established FDA program of abbreviated approval for “biosimilar” products

Answer 29

Biologics Price Competition and Innovation Act (2009)

Question 30

Which Regulatory Acts:

Were the first legislative efforts to promote research on drug efficacy and safety in children

Answer 30

• Best Pharmaceuticals for Children Act (BPCA) [2002]
• Pediatric Research Equity Act (PREA) [2003]

Question 31

Which Controlled Substance class would be viewed as:

High abuse potential

Accepted Medical Uses

Answer 31

Class 2/2N

Question 32

Which Controlled Substance class would be viewed as:

High abuse potential

No Accepted Medical Uses

Answer 32

Schedule 1

(heroin, LSD, Marijuana)

Question 33

Which Controlled Substance class would be viewed as:

Moderate abuse potential

Accepted Medical Uses

Answer 33

Schedule 3/3N

Question 34

Which Controlled Substance class would be viewed as:

Lowest abuse potential

Accepted Medical Uses

Answer 34

Schedule 5

(cold remedies with codeine)

Question 35

Which Controlled Substance class would be viewed as:

Lower abuse potential

Accepted Medical Uses

Answer 35

Schedule IV

(tramadol)