Continuous-Time Model Identification of the Subglottal System.

Mathematical models that accurately simulate the physiological systems of the human body serve as cornerstone instruments for advancing medical science and facilitating innovative clinical interventions. One application is the modeling of the subglottal tract and neck skin properties for its use in the ambulatory assessment of vocal function, by enabling non-invasive monitoring of glottal airflow via a neck surface accelerometer. For the technique to be effective, the development of an accurate building block model for the subglottal tract is required.

Glottal Airflow Estimation using Neck Surface Acceleration and Low-Order Kalman Smoothing.

The use of non-invasive skin accelerometers placed over the extrathoracic trachea has been proposed in the literature for measuring vocal function. Glottal airflow is estimated using inverse filtering or Bayesian techniques based on a subglottal impedance-based model when utilizing these sensors. However, deviations in glottal airflow estimates can arise due to sensor positioning and model mismatch, and addressing them requires a significant computational load.

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties.

Background: To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issuing recommendations for practice.

Methods: A grouping of medical conditions with similar characteristics regarding the potential applicability of methods and designs was created using a consensus approach. The 125 dossiers for authorised OMP published between 1999 and 2014 on the EMA webpage were grouped accordingly and data was extracted from European Public Assessment Reports (EPARs) to assess the extent and robustness of the pivotal evidence supporting regulatory decisions.

Applicability and added value of novel methods to improve drug development in rare diseases.

Background: The ASTERIX project developed a number of novel methods suited to study small populations. The objective of this exercise was to evaluate the applicability and added value of novel methods to improve drug development in small populations, using real world drug development programmes as reported in European Public Assessment Reports.

Methods: The applicability and added value of thirteen novel methods developed within ASTERIX were evaluated using data from 26 European Public Assessment Reports (EPARs) for orphan medicinal products, representative of rare medical conditions as predefined through six clusters.

Comparison of the qCON and qNOX indices for the assessment of unconsciousness level and noxious stimulation response during surgery.

The objective of this work is to compare the performances of two electroencephalogram based indices for detecting loss of consciousness and loss of response to nociceptive stimulation. Specifically, their behaviour after drug induction and during recovery of consciousness was pointed out. Data was recorded from 140 patients scheduled for general anaesthesia with a combination of propofol and remifentanil.