التفاصيل البيبلوغرافية
| العنوان: |
Biometrical Aspects of Drug Development. |
| المؤلفون: |
Stock, G., Lessl, M., Venitz, J., Sittner, W., Machin, D., Tan, S -B. |
| المصدر: |
Appropriate Dose Selection - How to Optimize Clinical Drug Development; 2007, p195-207, 13p |
| مستخلص: |
Once the activity of a compound has been established in the laboratory (usually by use of experimental animals) the next stage of development is to bring this forward to humans in early-phase clinical trials. A pharmacokinetic study aims to establish an effective dosing regimen for the compound in order to reach concentrations within the therapeutic window as quickly as possible. The aim of the phase I trials is typically to determine a maximal safe dose with which more rigorous investigation of activity in a phase II trial can be conducted. This chapter deals with statistical issues related to the design of phase I studies. [ABSTRACT FROM AUTHOR] |
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