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The Probability of Registrational Success

  • Regulatory Affairs
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Abstract

Pharmaceutical industry drug development portfolios vary in breadth and depth. For each firm, however, the objective of improving the success rate of their marketing applications is paramount. Understanding some of the characteristics associated with marketing application success and alternatively some of the pitfalls associated with application failure may assist firms in developing more efficient drug development strategies. The purpose of this article is to review briefly some of the research that has been conducted, take note of current trends, underscore potential biases, and affirm the contribution that regulatory professionals can bring to the drug development process.

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Authors and Affiliations

  1. Regulatory Affairs, Purdue Pharma LP, Connecticut, 06901, Stamford, USA

    Charles A. Maniglia PhD (Executive Director)

Authors
  1. Charles A. Maniglia PhD
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Correspondence to Charles A. Maniglia PhD.

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Maniglia, C.A. The Probability of Registrational Success. Ther Innov Regul Sci 41, 345–347 (2007). https://doi.org/10.1177/009286150704100307

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