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  1. #31
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    JUST DO IT and the rest will come by ITSELF believe me.

    No its time to stand up for your hair and get this crap done.

    Btw would be nice if someone would then also post this link at hairsite because i am avoiding this site like the plague

  2. #32
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    i'll try to do it some point this week


    if anybody has any suggestions of what should be included in the preamble-- make it known here

  3. #33
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    Thank you consider myself to owe you one for this

  4. #34
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    Dec 2011
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    Clinical Drug development:
    Clinical Drug Development is divided into four phases (or 5 if ‘phase ‘0’ is
    counted). At all stages patients are monitored for side effects and information
    on drug safety is gathered as a priority.

    Phase 0 is a transitional phase between the pre-clinical testing stage and full
    clinical trials. Sub-therapeutic doses are monitored for any unexpected effects.
    This ‘phase’ is most commonly used in development of chemotherapeutic
    agents for cancer treatment.

    Phase I is relatively small scale, usually involving around 20-80 healthy
    volunteers (often undergraduate students) and is concerned primarily with dose
    finding and tolerability. Volunteers are given progressively larger doses of drug
    until an effect is registered. Information gathered during phase I will allow
    estimates to be made of the amount of drug the body will tolerate without
    causing side effects and what side effects might occur. Several rounds of Phase
    I trials may occur for any given drug, in different countries and patient groups.

    Phase II trials are of medium size, involving 100-300 patient volunteers. At this
    stage the drug is tested for effectiveness against a specific disease which will
    be the intended ‘indication’ of the drug. Again, several phase II studies may be
    performed for a given drug.

    Phase III are large scale trials involving 1000-3000 patients where
    effectiveness is tested again and comparison is made with other treatments that
    are available. If a drug survives phase III then it may be registered and sold as
    a therapeutic agent.

    Transition through phases I, II and III takes about 6-10 years. Of 100 drugs
    entering phase I only a few, maybe 10, will survive to phase II and of these only
    1 or 2 will make it to phase III. If a drug makes it to phase III then it has a
    reasonable chance of success. The costs of drug discovery and development
    are enormous and most of the costs are incurred at phase III so companies
    have to be confident of a reasonable chance of success before allowing a drug
    candidate to proceed to this stage.

    From one of my lectures , Its a bit weird how these companies claim to finish trials with 3-4/2-3 years, i hope this is some kind of fast track that only applies in the us.

  5. #35
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    Feb 2011
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    I don't agree with many aspects of that "Clinical Drug Development" piece. I don't agree with the long timeline that it supposedly takes for these drugs to reach the marketplace, the number of drugs that actually make it out of Phase I, II, etc., and several other things. With regards to Histogen, Replicel, and the rest of the hair loss drugs, I thankfully think that their trials will go much quicker since most of them (except for Aderans) are conducting them outside of North America so they don't need to be bogged down by many unnecessary FDA regulations and bureaucratic red tape.

  6. #36
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    Dec 2011
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    I think these are the rough guidlines in the uk.

  7. #37
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    Jan 2011
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    Push again because shills are starting to write in the scam TRX2 thread which annoys me

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