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Considering that to optimize drug development, it is important to anticipate go/no-go decisions. Our aim is to show the usefulness of electrophysiological markers in early clinical phase decision-making studies. In particular, our purpose is to illustrate the usefulness of wake electroencephalography (wake EEG) and polysomnography (sleep EEG) techniques in optimizing central nervous system (CNS) drug development by giving an overview of some phase 1/2a study results in which these techniques were applied. The possibility of defining at the earliest time the potential of the CNS active compound passing the blood-brain barrier, if it does (its minimal active dose and dose/time effects), is addressed. The ways to obtain more powerful assessments of its pharmacological activity and pharmacodynamic profile are also shown as well as inputs toward potential therapeutic indications. Finally, to show the predictive power of these techniques, the link between the surrogate markers, and the clinical outcomes are examined. Examples of discriminating between electrophysiological techniques based on their relative advantages and applications are given depending on the characteristics of the compound and aims of the study. In addition to the above mentioned uses, electrophysiological markers may also provide an important warning of possible adverse effects and use in diagnosis of CNS diseases.
D'Aniello F, Lincker T, Luthringer R, et al. Electrophysiological Surrogate Markers in Clinical Development of CNS Active Compounds. Arch Neurol. 2000;57(8):1238. doi:
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