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NBME 24 Answers

nbme24/Block 3/Question#7 (23.9 difficulty score)
A 21-year-old woman with asthma comes to the ...
Phase 3πŸ”

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 +4  upvote downvote
submitted by famylife(77),
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usmile1  also just to verify, there is no such thing as phase 0 right? +  
madojo  Not that i know of or is in FA +  
llamastep1  I've heard animal testing is called phase 0. +1  

 +3  upvote downvote
submitted by madojo(122),

FA 19 256

Does the drug SWIM? Phase 1 - small number of volunteers assess for Safety Phase 2 - moderate number of patients, does it Work Phase 3 - large number random assignment, with placebo, any Improvement? Phase 4 - hit the market, any unexpected side effects, can be withdrawn from Market

kpjk  just would like to make a small correction phase 3- not placebo, but a drug already present in market so to test if there is improvement over standard care phase 2- would have the placebo, to see if the drug is actually working thats why i got confused in this question couldnt phase 2 also have randomized,prospective double blinded study +3  
kpjk  Sorry! Just saw FA- it says even placebo can be used in phase 3 +1  
llamastep1  Ugh I over thought it, I figured if you wanna give your patient a new treatment you wouldn't send her to possibly receive PLACEBO, am I the only who thought this? +  
turtlepenlight  for the vast majority of drugs, the FDA / NIH don't allow placebo testing anymore (regardless of FA!) +  

  1. Phase I Small number of either healthy volunteers or patients with disease of interest. β€œIs it Safe?” Assesses safety, toxicity, pharmacokinetics, and pharmacodynamics.

  2. Phase II Moderate number of patients with disease of interest. β€œDoes it Work?” Assesses treatment efficacy, optimal dosing, and adverse effects.

  3. Phase III Large number of patients randomly assigned either to the treatment under investigation or to the standard of care (or placebo). β€œIs it as good or better?” Compares the new treatment to the current standard of care (any Improvement?).

  4. Phase IV Postmarketing surveillance of patients after treatment is approved. β€œCan it stay?” Detects rare or long-term adverse effects (eg, black box warnings). Can result in treatment being withdrawn from Market.

So does someone know what is phase 0 for? It was an option... somathing like "let me see if i can study this thing?"

cheesetouch  via google - A Phase 0 study gives no data on safety or efficacy, being by definition a dose too low to cause any therapeutic effect. Drug development companies carry out Phase 0 studies to rank drug candidates in order to decide which has the best pharmacokinetic parameters in humans to take forward into further development. +  
boostcap23  Phase 0 is an extremely small dose (1% of normal) given to easily rule out any harmful effects. Basically used as a quick way to eliminate further trails/research on drugs that don't work. +1