Studies with two investigational interventions: a simple model to assess their effects and interaction.
The paper presents a simple way to design and analyse studies on pharmacodynamic food-interaction and drug-interaction studies. The study design includes two distinct interventions--the drug or control against eating, or fasting, and allows an analysis of variance. It provides a model for a more analytical approach in the conduct and analysis of pharmacodynamic interaction studies and pharmacotherapeutic combination trials.
de Mey
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C
SK&F Institute for Applied Clinical Pharmacology, Göttingen, Federal Republic of Germany.
Sparrow
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P
D000704:Analysis of Variance; D001262:Atenolol / Q000494:pharmacology; D004347:Drug Interactions; D004435:Eating; D005215:Fasting / Q000378:metabolism; D006801:Humans; D010600:Pharmacology / Q000379:methods*; D010919:Placebos
D010919:Placebos; D001262:Atenolol