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Researching a new drug

Discussion in 'Pharmacy' started by mike36, Mar 22, 2007.

  1. mike36

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    Can someone give me some information on what all is involved for new drug research? I'm only interested in new molecular entities (not the ******ed "me too" drugs). I'm thinking first a target for a drug needs to be discovered/isolated and studied for structure and function, like a new protein. Then, I guess a new drug can be chemically built that will modify or change the function of this target. How do clinical trials work? I've heard of Phase I, II, III. Thank you for your help.
     
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  3. canggar

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    1. Most "me too" drugs are new molecular entities. For example, prozac/fluoxetine was the first SSRI approved. Subsequent SSRIs could be called "me too" drugs, even though they are different molecules. "Me too" really just means the drug is not always a big clinical improvement on what is already available - it doesn't mean it is not a new molecule.

    2. Most drug companies today have a staggering (millions?) number of chemicals already made for high-throughput screening. They set up an in vitro assay that can be done very quickly (ideally it will use light absorbance or something that is easy to measure) to find the best candidate molecules called leads. These leads may or may not be optimized by chemically modifying the core lead structure to adjust it's target affinity, hydrophillicity etc. These leads are then tested in animals.

    3. Molecules that do well in the in vitro test and animal tests may (and the overwhelming number of molecules do not) go on to phase I testing (safety only in healthy humans). Pass that test then it's phase II (small number of patients with disease, safety and efficacy). Pass that and finally it's phase III (large number of patients with the disease to see if the drug works with a tolerable safety profile).
     
  4. Farmercyst

    Farmercyst On with the Poodles already
    Pharmacist Moderator Emeritus

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    We had a seminar in for our chemistry department by a team leader for arena pharmaceuticals in San Diego, he said pretty much as above. He had a little more details as to what "high-throughput screening" is. I don't remember a whole lot about it though. The point is go to the ones who know. If someone on faculty has connections to a company (This guy was a CSUSB alum) you might be able to get the information straight from the horse's mouth.
     

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