New Drug Development

Front 1

food, drug, and cosmetic act?

Back 1

require evidence of safety (relative to context of clinical situation)

Front 2

kefauver-harris drug amendments?

Back 2

requires evidence of efficacy (benefit outweighs risks)

Front 3

routes of discovery of new drugs?

Back 3

identification of new drug target, rational drug design, modification of known molecule, screening of natural products and chemical banks, biotechnology, combining known drugs

Front 4

what info obtained from screening and safety testing?

Back 4

efficacy and other unexpected benefits, identification of mechanism, what should be monitored in clinical trials

Front 5

limitations of animal testing?

Back 5

not necessarily extrapolated to human, rare adverse effects in humans, ethics of animal testing

Front 6

IRB and purpose?

Back 6

institutional review boards: protect human subjects in research studies (minimized risk, informed consent, subject selection, risks reasonable, protect privacy and maintain confidentiality)

Front 7

IND and NDA timing?

Back 7

IND before human trials to assess safety, chemical stability, clinical protocols;
NDA after human trials to reassess data, safety, efficacy, labeling, manufacturing methods

Front 8

phase 1?

Back 8

20-100 normal volunteers for safety and pharmacokinetics

Front 9

phase 2?

Back 9

100-200 pts with disease for efficacy

Front 10

phase 3?

Back 10

1000-6000 pts with disease for efficacy on large scale, double blind, at multiple centers as intended for use

Front 11

trial monitoring?

Back 11

look at results as come in to assess toxicity or extreme efficacy

Front 12

post-marketing surveillance?

Back 12

continued clinical trial phase surveillance, identification of new adverse effects

Front 13

adverse events to be reported?

Back 13

death, life-threatening, hospitalization, disability, congenital anomaly, requires intervention to prevent permanent impairment or damage