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Activity Number:
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320
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Type:
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Contributed
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Date/Time:
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Wednesday, August 14, 2002 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section*
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| Abstract - #301945 |
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Title:
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On Monte Carlo Simulations in New Drug Development
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Author(s):
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David Carlin*+ and Harry Yang
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Affiliation(s):
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MedImmune, Inc. and MedImmune, Inc.
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Address:
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35 W. Watkins Mill Rd., Gaitherburg, MD, 20878, USA
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Keywords:
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Monte Carlo Simulation ; Sample Size ; Type I and Type II errors ; Stochastic Process Control
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Abstract:
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Sample size determination, selection of statistical test methods for clinical trials and establishing stochastic process control criteria for positive assay controls that are used for drug lot release testing are important statistical aspects for new drug development. In this paper, we describe how to use Monte Carlo simulation methods to estimate sample size that can not be readily determined by commercially available software packages, to compare inferential properties of statistical tests, specifically, the Fisher's exact test and chi-square tests with/without continuity adjustment, and to aid the development of stochastic process control criteria for tracking potentially out of control positive standards that are used for drug lot release testing. It is shown that the Monte Carlo methods are useful computer-based techniques for obtaining insights into complicated statistical issues in new drug development without resorting to the formidable statistical theory.
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- Authors who are presenting talks have a * after their name.
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