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    The drug development process involves screening thousands of potential drug compounds through pre-clinical and clinical trials over 10-15 years, with only 1 in 5,000 to 10,000 compounds making it through to FDA approval. Pre-clinical discovery and testing narrows thousands of compounds down to around 250 for animal testing. If successful, compounds then progress through Phase I-III clinical trials involving increasing numbers of human volunteers to test safety and efficacy before final FDA review and potential approval. The average total cost of bringing a new drug to market is over $1 billion.

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    Drug development process

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    The drug development process involves screening thousands of potential drug compounds through pre-clinical and clinical trials over 10-15 years, with only 1 in 5,000 to 10,000 compounds making it through to FDA approval. Pre-clinical discovery and testing narrows thousands of compounds down to around 250 for animal testing. If successful, compounds then progress through Phase I-III clinical trials involving increasing numbers of human volunteers to test safety and efficacy before final FDA review and potential approval. The average total cost of bringing a new drug to market is over $1 billion.

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    5 views1 page

    DrugDevelopmentProcess PPD Infographic

    Uploaded by

    nosgothsoul
    The drug development process involves screening thousands of potential drug compounds through pre-clinical and clinical trials over 10-15 years, with only 1 in 5,000 to 10,000 compounds making it through to FDA approval. Pre-clinical discovery and testing narrows thousands of compounds down to around 250 for animal testing. If successful, compounds then progress through Phase I-III clinical trials involving increasing numbers of human volunteers to test safety and efficacy before final FDA review and potential approval. The average total cost of bringing a new drug to market is over $1 billion.

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    of 1

    DRUG DEVELOPMENT PROCESS

    10,000-15,000

    Compounds

    250

    Compounds

    6-7 YEARS

    3-6 YEARS

    Drug
    Discovery

    Pre-discovery

    Preclinical

    0.5-2 YEARS

    FDA
    Review Manufacturing

    Clinical Trials
    Phase I

    Phase II

    Phase III

    20-100
    Volunteers

    100-500
    Volunteers

    1,000-5,000
    Volunteers

    IND Submitted

    AVERAGE COST: $1 billion+


    *Source: ACRO

    1 FDA-Approved Drug

    5 Compounds

    Phase IV
    Post-Approval

    NDA Submitted

    DURATION: 10-15 years*


    ppdi.com

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