drug development pipeline

Question 1

what are first in class drugs

Answer 1

targets a protein that hasnt been targeted before by another drug

Question 2

what are me-too drugs

Answer 2

targets a protein that has ben tergeted before by another drug

Question 3

what is the drug development pipeline

Answer 3

shows three main categories of drugs — those that are in preclinical development, clinical trials or approved for use

Question 4

how does drug development pipelike reduce risk

Answer 4

it is a stepwise de-risking of a drug candidate from one step to the next

Question 5

what is the world health orginization list of essential medicines

Answer 5

• list of essential medicines
• focuses on SERIOUS disease, not minor ones
• takes into account how common and serious disease is, public/community health, if the drug works, if the drug is safe, if it is cost-effective

Question 6

what are considerations in early drug development

Answer 6

• how needed is the drug? (is it life-threatening etc.)
• how good is current the current therapy for the disease? (how could it be better)

Question 7

what is the drug discovery phase

Answer 7

• disease is chosen
• drug target it found, usually a molecule/protein that is involved in the disease that the drug can bind to
• disease model is made, animals (needs to be safe in at least 2 animals for FDA approval)

Question 8

what are phase 1 clinical trials

Answer 8

• typically use healthy people first
• to determine if the drug is a safe dose
• to find out what happens to the drug in the body
• they start small from 100x to 1000x smaller than usual
• subjects are volunteers or patients THEY MUST GET CONSENT

Question 9

what are phase 2 clinical trials

Answer 9

• to obtain preliminary information on how efficient the drug is
• to find out if the drug works to treat the condition
• subjects are the patients with the disease
• compare treated individuals to control individuals (use placebo)
• usually use blinding

Question 10

what is placebo

Answer 10

• look like real pills but contain no active drug ingrediant
• placebo affect is related to expectation of the drug working

Question 11

what is blinding in phase 2 clinical trials

Answer 11

• single blind : the subjects don’t know who is getting treatment and who is getting placebo
• double blind : the subject and investigators don’t know who is getting treatment and who is getting placebo

Question 12

what is phase 3 clinical trials

Answer 12

• compare efficiency of new treatment with the standard regimen
• they use a randomized control
• subjects are patients with disease

Question 13

who approves drugs

Answer 13

government agency

Question 14

do drugs have patents

Answer 14

yes!