I’m writing a story- as I tend to do, for my own enjoyment. And for the college creative writing club. Anyhoo, I need to do research on how pills are made- where the money comes from, what kind of research can you do WITHOUT an FDA approval, and how the actual pill is physically made. I know, I know, you’re all saying that I’m a lazy ass and should try to do this research on my own, but it’s not working out. I tried google- all I got was penis enlargement pills. Same with the other inferior search engines. And the campus library? Not working out. Public library? Too far away and me sans car. Pay someone else to do it?? Yeah right- I’m starving student here.
So I’m asking- very nicely- if anyone has any information on any of these topics, or has any idea of where I could go to find information. Anyone?
Oh yeah, and does anyone know if there are any animals that display homosexual tendencies?
Thanks a million for any answers.
I once worked at a pharmaceutical company helping with product development of an implant device. Not quite the same as a pill, but I do believe the route to FDA approval is the same. Therefore, for your perusal, here’s a rough generic outline of the path to FDA approval for a new medicine based on my experiences.
Somebody somewhere makes a discovery that a certain compound may prove beneficial in curing or treating a disease. This is almost always done at a university. Money for this initial research comes from grants from such institutions as the National Institute of Health, the Keck Foundation, the American Cancer Society, and the Howard Hughes Medical Institute.
Pharmaceutical companies have people on staff who scour scientific journals and patent offices searching for these discoveries. When they find one they’re interested in, they research it extensively, ascertaining if it’s something they feel can be useful in their corporate plan. If it is, then they’ll research who has prior claim to it, and offer the researcher or researchers involved a fee for permitting them to use the discovery to try and derive therapeutic benefits.
Once they have permission to use the discovery, they typically begin animal studies if these have not previously been done. They then move on to pre-clinical studies, and later clinical studies. The FDA scrutinizes this whole process and must give approval before the next phase can be entered. If animal testing shows (just a random madeup example here) that treatment X which is supposed to cure warts results in the test subjects developing brain tumors, then the FDA won’t give approval for pre-clinical trials. If everything is up to par with all of the trials, the FDA will ultimately give approval for the manufacturing and distribution of the final product. The cost for this is usually paid by the company doing the investigations, though it is possible for a pharaceutical company to obtain grant funding to pay a portion of these expenses.
