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| Standard Phases of Drug Development |
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| Phase | | | | | | Average chance of success, % |
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| Preclinical |  |
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Development decision |
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Safety evaluation in animals; pilot plant scale production process; formulation for phase I |
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Approval to treat first human subject |
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| I | |
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Start of first tolerability and kinetic study in humans |
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Safety, tolerability and kinetics in humans; extended toxicology; formulation for phase II |
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Approval to start first therapeutic study |
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| II | |
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Start of first therapeutic study |
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First proof of therapeutic efficacy; determination of effective dose; longer term toxicology |
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Approval to start large pivotal therapeutic studies |
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| III | |
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Start of first large pivotal study |
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Statistical proof of efficacy and safety in a large, diverse patient population; documentation of all results; process optimization and scale up |
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Completion of documentation for regulatory submission |
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| Approval | |
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Submission in first country |
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Response to questions and requests of regulatory authorities; production of launch supplies; premarketing and sales force training |
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| Marketing approval | | |