[The challenges of the implementation of the European Directive 2001/20/CE in the main Member States].

Since the publication of Directive 2001/20/EC in the Official Journal of the European Communities on May 1, 2001, the Member States have been preparing its transposition into national legislation for application no later than May 2004. The discussions have proved to relate essentially to the organisation of the Ethics Committees, which must now give a single opinion per Member State, as well as to the time limits for obtaining this opinion and the authorization for a study from the competent authority. These considerations have led to proposals of shorter time limits for products at an early stage of development or involving certain diseases.

[Congenital long QT syndrome in newborns].

Unlabelled: The perinatal manifestations of the long QT syndrome are rare, but early diagnosis and therapy are necessary to prevent sudden death.

Case Reports: A long QT syndrome was diagnosed in two neonates who presented with foetal bradycardia. In one case, a mutation in the gene KCNQ1 was identified, and a long QT syndrome was diagnosed in the mother and two brothers of the neonate.

[An unrecognized neonatal emergency: extensive hematoma of the scalp. 5 cases].

Background: Subgaleal hemorrhage results from a pericranial effusion of blood subsequent to neonatal trauma. This exceptional situation compared with other pericranial effusion conditions in the neonate may be life-threatening.

Case Reports: We report the obstetrical and neonatal data in 5 cases of subgaleal hemorrhage observed in our unit over an 8-year 8-month period.

Simulation of pulmonary damages induced by inhaled Cl2 on the bronchial tree.

We have measured the change of lung mechanical parameters on isolated rabbit lungs exposed to chlorine gas (Cl2). Experimental results show parallel increase in elastance and resistance of impaired lungs. We tried to determine whether this may be explained by a reduction of the ventilated areas in the lung, consecutive to closure of some airways.

Development of a population pharmacokinetic database for tianeptine.

Two thousand three hundred and thirty five plasma concentrations of tianeptine from 112 patients enrolled in nine studies of tianeptine pharmacokinetics performed prior to the marketing of the drug were pooled for analysis using mixed-effect modeling. Studies represented a combination of single dose and multiple dosing at steady-state. Tianeptine plasma concentration time data were fit to a two compartment model with first order absorption using the NONMEM computer program.