title: Exploring clinical study design by computer simulation based on pharmacokinetic/pharmacodynamic modelling.
abstract: Computer simulations have been successfully applied in various industries (e.g. automobile, aerospace) to make product development more efficient. Just recently, it was suggested to use simulations in support of clinical drug development for predicting clinical outcomes of planned trials. The methodological basis for this approach is provided by pharmacokinetic and pharmacodynamic mathematical models together with Monte Carlo techniques. In the present paper, the basic notions of clinical trial simulation are introduced and illustrated with the example of an oral anticancer drug. It is shown that computer simulation helps to evaluate consequences of design features on safety and efficacy assessment of the drug which are not easily obtained otherwise. An overview of existing simulation resources with respect to training and software is provided.
authors.affiliation: Pharma Development, F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Gieschke
authors.forename: B G
authors.initials: BG
authors.lastname: Reigner
authors.forename: J L
authors.initials: JL
authors.lastname: Steimer
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000493:pharmacokinetics* / Q000494:pharmacology*; D002986:Clinical Trials as Topic / Q000379:methods*; D003198:Computer Simulation; D006801:Humans; D008954:Models, Biological; D009010:Monte Carlo Method; D012107:Research Design; D015983:Selection Bias
chemical_list: D000970:Antineoplastic Agents