Intro to pharmocology- Dr. Pechnick

Question 1

what is pharmacology

Answer 1

the study of interaction with of drugs with living biological systems.

Question 2

A pharmacologist researches and invents new drugs for the ____ to dispense

Answer 2

pharmacist–> deals with end products of pharmaceutical industry. Namely mix, supply, and advise dosages of drugs

Question 3

What are the two closely related areas that pharmacology can be divided into

Answer 3

1. Pharmacokinetics

2. Pharmacodynamics

Question 4

Pharmacokinetics deals with the absporption, distribution, metabolism and ____ of drugs

Answer 4

excretion; what the body does to the drug

Question 5

Pharmacodynamics is the study of the molecular, biochemical and physiological effects of drugs on cellular systems and their mechanisms of action:

Answer 5

what the drug does to the body when it gets there

Question 6

How are drugs discovered?

Answer 6

1. by screening natural products. Ex: curare
2. testing herbal/traditional medicine. Ex: curcuma longa/turmeric
3. molecular modeling: shows 3 dimensional structure of enzyme and try to get drug to fit in pocket.
4. Combinatorial chemistry and high throughput screening: prepare parent compound in test tube and make analogs and screen compounds but have to know what your looking for
5. me too drugs
6. son of a drug
7. repurposing/repositioning:

Question 7

What are “me too” drugs

Answer 7

Anti depressant drugs; SSRIs

Question 8

what are ex of “me too” drugs

Answer 8

1. prozac
2. celexa
3. lexapro
4. paxil
5. zoloft
   pharmacology is the same but small differences

Question 9

what is “son of a drug”

Answer 9

1. Resolve and separate enantiomers: prilosec/nexium

2. active metabolites: seldane/allegra

Question 10

what is repurposing/repositioning

Answer 10

same drug, but used for a new use

Question 11

How did drug laws come into place

Answer 11

Pure Food and Drug Act of 1906:

1. Proof of efficacy/safety not required
2. required proper labeling
3. limited interstate transport of misbranded/adulterated drugs
   * Led to the creation of the FDA

Question 12

Food Drug and Cosmetic Act of 1938

Answer 12

1. Proof of safety was required
2. Proof of efficacy not required.
3. Toxicity testing required in animals
4. A new drug application had to be filed with the FDA prior to approval

Question 13

What is thalidomide

Answer 13

A drug marketed primarily in Europe in 60’s as a tranquilizer for pregnant women who had nausea. 2,000 children and serious birth defects in more than 10,000 children
*teratogenic

Question 14

What is Harris Kefauver Amendment of 1962

Answer 14

1. Both safety and efficacy had to be proven
2. Required documentation of risk to benefit ratio
3. Gave the FDA authority to regulate advertising
4. began to classify all pre 1962 drugs already on the market as effective, ineffective or needing further study.

Question 15

What are the various phases of drug testing

Answer 15

1. preclinical testing:
2. Phase I
3. Phase II
4. Phase III
5. Phase IV

Question 16

what are the goals of drug development

Answer 16

1. inc efficacy
2. work faster
3. easier to take
4. fewer adverse reactions (side effects)
5. fewer drug-drug and drug-food interactions
6. profit

Question 17

what is the preclinical testing phase

Answer 17

invitro, in vivo

• establishes a “proof of concept”
• file for investigational new drug (IND)
• time required to comp: 3-6 years

Question 18

what is Phase I testing

Answer 18

1. uses normal volunteers
2. determines safety and biological effects
3. efficacy is not studied
4. assesses pharmacokinetics (absorption, distribution, metabolism, and excretion)
   Time required to complete: months- 1 year

Question 19

what is Phase II testing

Answer 19

1. Studies a small number of patients with the targeted disease
2. Efficacy is established
3. Pharmacokinetics characterized
4. dose range is determined
5. short term side effects and risks are assesed
   time req to complete: 1-2 years

Question 20

what is Phase III testing

Answer 20

• most costly phase
  1. large, multi site sample of patients
  2. safety and efficacy established
  3. drug-drug interactions assessed
  4. risk-benefit info generated
  5. Time req: 3-5 years

Question 21

FDA review can take:

Answer 21

1-2 years

Question 22

how long does it take to develop a new drug and receive approval

Answer 22

12 years

Question 23

how long are drug patents for

Answer 23

20 years

Question 24

What is the total cost to develop a single drug

Answer 24

$186 million to 2.6 billion

Question 25

What is Phase IV

Answer 25

additional uses of the drug are discovered.

• Post marketing surveillance:
• identify new/unusual adverse rxns
• incidence of adverse effects might be low
• adverse effects might require chronic exposure

Question 26

what is the black box warning

Answer 26

way FDA communicates with health care profesisonal and patient
*use with caution

Question 27

FDA use in pregnancy ratings

Answer 27

Usually category B: No evidence of risk in humans. No controlled studies have been conducted in humans, animal studies show no risk to the fetus

Question 28

How are drugs named

Answer 28

1. chemical name
2. company code name
3. US adopted name
   - If drug approved the company gives it a proprietary name (trade name)
   - after patent expires any company can market the drug under the generic name

Question 29

sources of info about drugs

Answer 29

physicians desk reference, FDA site, medical letter, micromedix, epocrates

Question 30

look up different pregnancy labels on drugs!

Answer 30

look at pp