Before a medical organization puts out a new medicine what precautions must they take? ex. # of people testing

Question

please tell me everything you know about this topc.

Answer 1

drugs go through preclinical then clinical trials before a drug can go to market. after a drug is labeled, the parent company may still continue nonclinical testing....

the major precaution is to get enough volunteers so that data generated is statistically significant while attempting to keep overhead low...because big pharma wants to keep all it's money...

furthermore

the FDA does not analyze test results, it goes over the already analyzed results from a company and determines whether there was enough information presented such that the companies' claims are valid.

Answer 2

Phase 1 of clinical testing uses about 10 healthy volunteers.  Phase 2 uses about 100 volunteers with the illness.  Phase 3 uses about 500 to 1000 volunteers with the illness.  Toxicological studies are performed before clinical tests.  During all phases, side effects and their frequency are noted as well as the patients response to them.  Dosages are studied mostly during phase 1 and 2 and then perfected in phase 3.  Long terms effects are studied during phase 4, after the drug is on the market.  

From concept to market, the average drug company will test thousands of potential drugs and spend over 100 million dollars for a single market drug.  After this they usually have about 5 years left on the patent for the drug and that's the time that they use to recover the cost of production, turn a profit, and fund future research.

Answer 3

A pharmacutical company can not put out a drug until it has been tested using the real drug on some volunteers and a placebo on other volunteers, noboby know but the testers know who is taking what.  A placebo is a fake maybe aspirin something safe that causes the volunteer to believe he/she is taking the real medicine.  This takes more than a year and many more years of research before.  Then the FDA has to approve the drug by analyzing the test results of the pharmacutical company.

Many times pharmacuticals will hire outside independant testers after they feel that a drug is viable.