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howladmin
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4139 posts
Jun-11-04, 03:26 PM (CST)
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"Where Drugs Come From"
 
   LAST EDITED ON Oct-27-07 AT 10:32 AM (CST)
 
Hi all:

I've noticed that people have the same questions again and again about how drugs are designed and approved. The FDA has a magazine, FDA Consumer, available to the public. A few years ago they wrote an article called "From Test Tube To Patient: New Drug Development in the United States". If anyone is interested in learned about the drug approval process this is a nice read.

The 1999 version is available as a PDF file.

http://www.fda.gov/cder/about/whatwedo/testtube-full.pdf

The 1995 Version is available on html.

http://www.fda.gov/fdac/special/newdrug/ndd_toc.html

The 2006 update is available online:

http://www.fda.gov/fdac/special/testtubetopatient/default.htm

Best,

Howl


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  Subject     Author     Message Date     ID  
  Thanks.. I anchored it so it stays on top. Rajahadmin Jun-13-04 1
  Short History of the FDA howladmin Aug-13-04 2
     RE: 1 page chart muffinadmin Nov-27-04 3
         Nice Graphic howladmin Nov-27-04 4
             RE: Harvard Law Study - FDA z Jan-19-05 5
  RE: Where Drugs Come From Biostudent26 Mar-01-06 6
  Thread locked due to spamming.. Rajahadmin Aug-01-06 10
  RE: Where Drugs Come From davidchen Feb-11-12 11

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Rajahadmin
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15328 posts
Jun-13-04, 12:42 PM (CST)
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1. "Thanks.. I anchored it so it stays on top."
In response to message #0
 
"Do the Right Thing. It will gratify some people and astound the rest." - Mark Twain


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howladmin
Charter Member
4139 posts
Aug-13-04, 08:09 AM (CST)
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2. "Short History of the FDA"
In response to message #0
 
   In case anyone was curious about the origns of the FDA and how its authority was expanded over time, here is a short history.

http://vm.cfsan.fda.gov/~lrd/history1.html


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muffinadmin
Member since Sep-10-04
6230 posts
Nov-27-04, 09:41 AM (CST)
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3. "RE: 1 page chart"
In response to message #2
 
LAST EDITED ON Jan-23-10 AT 05:02 PM (CST)
 
"Drug development process"

I think this piece is an excellent 1 page summary of the drug discovery process from pre-clinical phase through market in a quick-n-easy 1.

The average drug takes 10-15 years and $802 million in order to make it to market and available to the public.

http://www.phrma.org/newmedicines/newmedsdb/phases.pdf

*2/22/2006: This old link no longer works. Here's a link to similar information describing the Phases etc.:
http://www.phrma.org/index.php?option=com_content&task=view&id=382&Itemid=118

*1/23/2010: Unfortunately, these links no longer work. Here's an alternative from clinicaltrials.gov <http://clinicaltrials.gov/ct2/info/understand#Q19>:
What are the phases of clinical trials?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase I trials, researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase II trials, the experimental study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase III trials, the experimental study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

In Phase IV trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

muffin ~ GHSV1 since 1986

Anyone who has sex is at
risk for getting herpes.

muffin through the years...

http://racoon.com/images/muffi
n.gif
http://racoon.com/images/muffi
n2.gif
http://racoon.com/images/muffi
n3.jpg
http://racoon.com/images/vamp_
muffin.jpg
Paragraphs are a wonderful
thing.


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howladmin
Charter Member
4139 posts
Nov-27-04, 11:04 AM (CST)
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4. "Nice Graphic"
In response to message #3
 
   Thanks Muffin


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z
Guest
Jan-19-05, 06:02 PM (CST)
 
5. "RE: Harvard Law Study - FDA"
In response to message #4
 
   Below is a link to an interesting harvard law lecture about the FDA and problems and solutions to their approval process.

http://leda.law.harvard.edu/leda/data/40/koliver.html


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Biostudent26
Guest
Mar-01-06, 06:00 PM (CST)
 
6. "RE: Where Drugs Come From"
In response to message #0
 
   There may not be a cure in our lifetime, but it's likely there will be a competing drug with Valtrex and other anti-virals that may lower the transmission rate even further in the near future.
The broad KEYS TO DRUG DESIGN are binding ability and affinity.

This is a pretty good analogy of an extremely complex concept.
It works similar to a lock and key.
You can have a key that inserts into a lock, but doesn't necessarily open it.
And you can have a key that opens a lock, but it isn't the key that the lock came with.
Furthermore, you can have the right key that came with the lock.
Valtrex and other antivirals might be that second option. The next drug to come out might be a better key for our "H locks".
Hope this helps to understand how many drugs work.


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Rajahadmin
Charter Member
15328 posts
Aug-01-06, 08:18 AM (CST)
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10. "Thread locked due to spamming.."
In response to message #0
 
"Do the Right Thing. It will gratify some people and astound the rest." - Mark Twain


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davidchen
Member since Feb-9-12
30 posts
Feb-11-12, 03:32 AM (CST)
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11. "RE: Where Drugs Come From"
In response to message #0
 
   I myself have had genital herpes for several years. Way back when, I remember what the doctors told me. It didn’t make sense. I wish there had been more resources available. I felt like I had to navigate the waters all by myself.
I personally have found peace and happiness. If you haven’t, you will. Ignorance and denial is not the solution. Be informed… learn the truth… here at Pozmingles.com. which have more than 600000 memebers according some news and it have provided many services such as chatting,blogs,test center,forum etc.


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