Multiple-dose phase I trials--normal volunteers or patients? One viewpoint.
Traditionally, Phase I tolerance trials have been done with normal volunteers to establish single- and multiple-dose tolerance. We feel that the justification for doing multiple-dose tolerance studies in normals is open to question and that, in fact, more pertinent data can be generated by using the appropriate patient populations for these studies.
D004305:Dose-Response Relationship, Drug; D004341:Drug Evaluation / Q000379:methods*; D004361:Drug Tolerance; D006801:Humans; D012107:Research Design