Currently some biomarkers are regarded as state markers such as genetics and related findings, in addition, several markers are putative trait markers. Both state and trait markers carry distinct information which provides the possibility of characterizing Afatinib treatment outcome better than mere

subjective measures. Definition The term “biomarker” is not always appropriately used, given the great diversity of methods and investigational procedures to identify the origin or “state” of psychiatric disorders. Moreover, for drug development it also appears necessary to identify “trait” alterations; this is of importance for identification of parameters monitoring Inhibitors,research,lifescience,medical the intrinsic course of illness on one hand and predicting the efficacy of treatment procedures on this intrinsic course on the other hand. From this point

of view for biomarkers individual dynamic responsiveness to interventions is also interesting. Absolute measures are helpful in identifying, Inhibitors,research,lifescience,medical eg, alterations in comparison of patients vs controls. However, of further interest is the way the individual response has to be classified: within the physiological bandwidth of homeostasis or at the borders of individual Inhibitors,research,lifescience,medical regulatory capacity. According to Frank and Hargreaves,1 biomarkers are characteristics which are objectively measured and evaluated as an indicator of the intrinsic causes

of illnesses, the clinical course, and its modification by treatment. In this Inhibitors,research,lifescience,medical context the authors point to the differentiation of clinical end points of treatment and surrogate end points: the former is for psychiatric approaches reflected by behavior and subjective feelings. For the latter the surrogate end point substitutes a clinical end point, to predict clinically wanted or unwanted effects. In addition, different types of biomarkers can in general be classified as shown in Table I 3: Table I Types of biomarkers. Inhibitors,research,lifescience,medical Another aspect comprises the terms sensitivity and specificity. Sensitivity and specificity are statistical 17-DMAG (Alvespimycin) HCl measures of the performance of binary classification tests. Sensitivity measures the proportion of measures or markers which correctly identify a condition, specificity measures the proportion of negative measures, which resembles the concept of Type I and Type II errors.4 In the spectrum of biomarkers there is considerable variability with regard to sensitivity and specificity. Up to now, and especially in the past decade, a multitude of procedures have been developed, which may be listed as follows (adapted from ref 5, but not an exhaustive list of approaches – Table II): Table II Targets of biomarkers.