Drug Development

Question 1

Drug Discovery phase

Answer 1

this is when many (5,000) compounds are tested

Question 2

Pre clinical

Answer 2

250 compounds tested

-used to determine risks and benefits

Question 3

clinical trials

Answer 3

• 5 compounds used
• split into 3 phases
• 1: 20-100 male volunteers
• 2:100-500 volunteers
  3: 1000-5000
• final test to prove safety and efficacy

Question 4

in order to go from clinical trials to FDA review

Answer 4

-you need an NDA

Question 5

IND (investigational new drug application

Answer 5

• required to be filed with the FDA before starting clinical trials
• FDA makes suggestions for trial design

Question 6

phase 4

Answer 6

• safety and efficacy tests done after approval
• off label side affects and uses of the drug are discovered at this time
• this can also be done when the patent for a drug has ran out and the generic brands are designed

Question 7

expenditures vs approvals

Answer 7

• approvals for new drugs have flattened

- expenditures on discovering and processing new drugs has gone way up

Question 8

most of the new drugs coming out on the market now are

Answer 8

incrementally modified, not new drugs

Question 9

what does risk evaluation and mitigation strategies include?

Answer 9

• medication guides
• dear provider lettes
• scheduled advertising
• special training to use the drug
• applicable for about a third of the new molecular entities

Question 10

what happened in the 1900’s

Answer 10

• federal food and drug act

- designed to prevent interstate commerce of adulterated food, drug, and beverage

Question 11

what happened in the 1930’s

Answer 11

food and drug act amended to include safety precautions for sulfanilamide and diethylene glycol and how they should not be used

Question 12

what happened in the 1960’s

Answer 12

• Kefauver-Harris amendment to food, drug and cosmetic act
• this was in response to thalidomide and laid the basis for the stringent efficacy testing that drugs need to go through now which are the 3 phases

Question 13

what happened in the 1990’s

Answer 13

• mean drug review time is 3 years
• Prescription drug user fee act which requires the developer of the drug to pay a fee to accomodate the amount of work done by the FDA to approve the drug and shorten the review time

Question 14

mean review time in 2010

Answer 14

1.2 years

Question 15

DSHEA

Answer 15

• dietary supplement health and education act
• amendment to food, drug, and cosmetic act
• 1994
• to establishstandards with respect to dietary supplements

Question 16

Rx drugs under the DSHEA act

Answer 16

• deemed safe and effective for intended use in humans prior to approval
• strict labeling includes info on indications, safety, efficacy
• usually 1 but sometimes 2 or 3 ingredients per pill
• label indicates exact ingredients
• potency and purity ensured

Question 17

dietary supplements under the DSHEA act

Answer 17

• Considered safe unless proven unsafe
• labeling not allowed to make disease treatment or prevention claims
• typically many active ingredients
• labels may or may not contain all ingredients

Question 18

sources of drug information

Answer 18

• primary: full text or original research about a drug or drug class.
• sencondary/tertiary: not an original work but a summary of it

Question 19

alternative sources of information

Answer 19

• internet
• professional organization
• drug information centers, poison control centers
• drug manufacturers

Question 20

MA drug schedules

Answer 20

1: high potential for abuse; no accepted medical use
2: high potential for abuse; currently accepted medical use
3-5: lesser potential for abuse
6: all other prescription drugs (penicillin)

Question 21

pregnancy risk categories

Answer 21

A: adequate studies in women have failed to show any risk to fetus in 1st tri or later
B: animal studies do not indicate risk and no controlled human studies OR animal studies do show harm, but well controlled studies in women do not
C: studies have shohwn teratogenic or embryocidal effects in animals, but no controlled studies in humans have been done OR no studies available in animals or women