[Experimental design in phase I (AUTHOR'S TRANSL)].
Clinical pharmacology has its domain during phase I. The formalisation of phase I is not very advanced. Sometimes it is argued that the design of experiments during that phase is unnecessary. Just the opposite is true. Trying a new substance for the first time in man poses a special necessity for the design of experiments in a scientific context. Phase I is described in a formal way. The design of experiments with a single subject -- the first one to be exposed to a new substance -- is described. Finally Latin squares are dealt with as a useful tool for phase I.
D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000379:methods*; D004358:Drug Therapy; D006801:Humans; D010361:Patients; D012107:Research Design; D013223:Statistics as Topic
Versuchsplanung in Phase I.