Document Server@UHasselt >
Research publications >
Please use this identifier to cite or link to this item:
|Title: ||On the use of historical control data in pre-clinical safety studies|
|Authors: ||MARINGWA, John|
Van Den Poel, B.
|Issue Date: ||2007|
|Publisher: ||TAYLOR & FRANCIS INC|
|Citation: ||JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 17(3). p. 493-509|
|Abstract: ||A number of methods to formally incorporate historical control information in preclinical safety evaluation studies have been proposed in literature. However, it remains unclear when one should use historical data. Focusing on the logistic-normal model, we investigate situations where historical studies may prove to be useful. Aspects of estimation (precision and bias) and testing (power) for treatment effect are investigated under different conditions such as the number of historical control studies, the degree of homogeneity amongst them, the level of treatment effect and different control rates. The possibility to use a selected subset of historical control studies is also explored.|
|Notes: ||Univ Hasselt, Ctr Stat, BE-3500 Diepenbeek, Belgium. Johnson & Johnson Pharmaceut Res & Dev, Beerse, Belgium.MARRINGWA, JT, Univ Hasselt, Ctr Stat, BE-3500 Diepenbeek, Belgium.email@example.com|
|ISI #: ||000246725000010|
|Type: ||Journal Contribution|
|Validation: ||ecoom, 2008|
|Appears in Collections: ||Research publications|
Files in This Item:
There are no files associated with this item.
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.