ILA: Drug Development and Scientific Method

Question 1

studies with single patient or small group of patients

Answer 1

case-reports/series

Question 2

observational study b/t 2 groups of people; similar exposure/risk factor where one groups developed disease and one didnt

Answer 2

case control studies

Question 3

observational analysis of large group of patients w/ similar challenges that have different outcomes; retrospective or prospective

Answer 3

cohort studies

Question 4

participants are randomized into 2 groups- one receives medicine or therapy; while the control group receives placebo; often double blind; large, well-designed studies can often influence treatment

Answer 4

randomized control trial (RCT)

Question 5

summary of all the best research on a topic

Answer 5

systematic review and meta-analysis

Question 6

regulations administered by the FDA require evidence of relative safety and probable therapeutic action before what

Answer 6

human testing

Question 7

after it is reviewed and approved by FDA who approves it last

Answer 7

NDA

Question 8

induction of developmental defects in fetus by drugs or toxins

Answer 8

teratogenesis

Question 9

induction of genetic mutation in animals of any age leading to induction of inheritable abnormalities

Answer 9

mutagenesis

Question 10

induction of malignant characteristics in cells

Answer 10

carcinogenesis

Question 11

combines phase I and II of drug development

Answer 11

antineoplastic drugs

Question 12

financial and operational incentives for development of drugs to treat rare diseases

Answer 12

orphan drugs

Question 13

most persuasive clinical study

Answer 13

randomized, controlled trials that are double blind