Biometrical aspects of drug development.
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.
Machin
D
D
UKCCSG-Data Centre, University of Leicester, Hearts of Oak Hous, UK. david.machin1@onetel.net
Tan
S B
SB
D000818:Animals; D001699:Biometry / Q000379:methods*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods*; D019295:Computational Biology / Q000379:methods; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval; D015195:Drug Design; D004353:Drug Evaluation, Preclinical; D023381:Endpoint Determination; D006801:Humans; D008962:Models, Theoretical; D010601:Pharmacology, Clinical; D012107:Research Design; D018401:Sample Size