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Risks of Inconclusiveness

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Phase II Clinical Development of New Drugs

Part of the book series: ICSA Book Series in Statistics ((ICSABSS))

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Abstract

During the entire clinical development of a new medicinal product, there are lots of milestones and decision points. Many of these key decisions could have long-term impact and involve a large amount of resources and investment. As indicated in previous chapters, the Go/NoGo decision after a PoC study is one of such examples.

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References

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Author information

Authors and Affiliations

  1. Boehringer-Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA

    Naitee Ting

  2. University of North Carolina, Chapel Hill, NC, USA

    Ding-Geng Chen

  3. University of Pretoria, Pretoria, South Africa

    Ding-Geng Chen

  4. PAREXEL International, Durham, NC, USA

    Shuyen Ho

  5. Pfizer, Inc., Groton, CT, USA

    Joseph C. Cappelleri

Authors
  1. Naitee Ting
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  2. Ding-Geng Chen
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  3. Shuyen Ho
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  4. Joseph C. Cappelleri
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Corresponding author

Correspondence to Naitee Ting .

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© 2017 Springer Nature Singapore Pte Ltd.

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Ting, N., Chen, DG., Ho, S., Cappelleri, J.C. (2017). Risks of Inconclusiveness. In: Phase II Clinical Development of New Drugs. ICSA Book Series in Statistics. Springer, Singapore. https://doi.org/10.1007/978-981-10-4194-5_7

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