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This is the preliminary program for the 2007 Joint Statistical
Meetings in Salt Lake City, Utah.
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The views expressed here are those of the individual authors and not necessarily those of the ASA or its board, officers, or staff. Back to main JSM 2007 Program page |
= Applied Session,
= Theme Session,
= Presenter| CE_08C | Sun, 7/29/07, 8:00 AM - 12:00 PM | CC-155 A |
| Dose Finding in Drug Development - Continuing Education - Course | ||
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Biopharmaceutical Section, ASA |
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| Instructor(s): Naitee Ting, Pfizer Inc., James MacDougall, Bristol-Myers Squibb Company | ||
| For dose finding study designs, the thinking process should start way before a drug candidate enters Phase II. Scientists need to make best use of data obtained from pre-clinical experiments and early Phase I trials, to learn from other drugs of the same class, and to understand the PK and PD properties of the drug candidate. It is also important to consider the formulation, the potential market environment and other similar drugs that may compete with the candidate under study. All these are important considerations for designing the dose response studies. After the dose response clinical data are collected, many statistical approaches are available to perform data analysis. The two main categories are modeling approaches and multiple comparison adjustments. Depending on stage of development and objectives of the study, appropriate method will be selected for data analysis. The usefulness of each approach under various situations will be discussed in this short course. | ||
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JSM 2007
For information, contact jsm@amstat.org
or phone (888) 231-3473. If you have questions about the Continuing Education program,
please contact the Education Department. |