[Elaboration of an interactive educational CD-R on good laboratory practices for manufacturing and quality control]. / Elaboration d'un CD-R interactif de formation aux bonnes pratiques de fabrication appliquées aux laboratoires de contrôle de la qualité.

cGMPs require that QA systems rely upon qualified personnel in charge of pharmaceutical operations. In order to achieve this legal requirement, the manufacturer must provide initial training and regular re-training along with periodical evaluations of their practical efficiency. This cGMP-learning multimedia CD-R is an interactive and individual training tool, designed for QC laboratory personnel. It contains a final questionnaire allowing an assessment of the course efficiency. Building up a ten-module teaching program entitled "Le médicament en toute confiance", the development of this CD-R was supervised by an European team of experienced industrial pharmacists.

Intraoperative endoscopic sphincterotomy is a reasonable option for complete single-stage minimally invasive biliary stones treatment: short-term experience with 57 patients.

BACKGROUND AND STUDY AIMS: How to approach common bile-duct (CBD) stones discovered during laparoscopic cholecystectomy (LC) is still a subject for debate. After sequential strategies, the natural trend is now towards single-stage therapy. The aim of this study was to establish the feasibility of intraoperative endoscopic sphincterotomy (IOES) when CBD stones are discovered or strongly suspected on intraoperative cholangiography (IOC) during LC. PATIENTS AND METHODS: Out of a total of 2193 laparoscopic cholecystectomies, we reviewed 57 patients who, between 1991 and 1999, underwent IOES just after LC during the same anesthetic session. Under fluoroscopic guidance, one group of 32 patients (Dijon) underwent IOES in the prone position and a second group of 25 patients (Poitiers) in the left lateral position. RESULTS: IOES was successful in all cases (100%). CBD stones were definitively found in 49 cases (86%) but retrieved or released into the duodenum after IOES in only 46 cases (46/49, 93.9%). The mean duration of the intraoperative endoscopic procedure was 28 minutes (range 15-75). The short-term complication rate was 7%. The mean postoperative hospital stay was 5.3 days (range 2-14). CONCLUSIONS: IOES performed after LC during the same anesthetic session is feasible with low risk and with good results. It offers the opportunity to treat in one stage both cholecystolithiasis and choledocholithiasis without the need for surgical CBD exploration.

Application of a liquid-crystal spatial light modulator for brightness adaptation in microscopic topometry.

Three-dimensional optical topometry of technical surfaces becomes increasingly important for the control of industrial processes. However, the local reflectance of the surface of the investigated sample often varies within a wide range, making accurate measurements by fringe projection difficult. We demonstrate the use of a liquid-crystal spatial light modulator as the fringe-generating element in a standard stereo microscope. With this device the brightness of the projected patterns can be adapted pixelwise. This technique leads to a significant improvement of the results of our measurements with a phase-shifting algorithm.

[Statistic determination of release limits of a finished product active principle compared to drug specification at peremption and eventually at the end of its after reconstitution]. / Détermination statistique des limites d'acceptation de la teneur en principe actif d'un produit fini par rapport aux spécifications du médicament correspondant à péremption et éventuellement au terme de son délai d'utilisation après reconstitution.

At manufacturing, finished dosage forms must meet the 75/318/EEC Directive particularly the criteria defining the potency registered limits i.e. +/- 5% variation of their nominal contents in general except some cases where sound justification can be provided on the basis of experimental results obtained at 95% confidence level. The described statistical method allows calculation of release limits of potency of any dosage form and applies to any parameter for which the rate of change with time is predictably uniform and linear. Assurance is then provided at 95% confidence level that any lot showing a mean release assay result within the calculated release limits will remain within registered limits at any subsequent time within its shelf-life. On the basis of real quality profiles including dozens of lots, the authors explains that the use of this statistical method leads to an efficient retrospective validation technic by means of chemical analysis.

[Spontaneous ureterocolic fistula. Concerning one case reviewed in the litterature (author's transl)]. / Fistule urètérocolique spontanée. A propos d'une observation, revue de la littérature

Among the entero-urinary fistulae, the most frequent are those fistulae which unite the sigmoid colon and the bladder. Fistulae between the ureter and the colon are ecxeptional as only two spontaneous ureterocolic fistulae have been reported. With reference to one case, the authors review the different complementary examinations which enable making the diagnosis and discuss the therapeutic attitude, which differs depending on whether the kidney above the fistula is functional or not.

[Urinary and vascular complications of a gastrointestinal tumour. Clinical picture and therapeutic problems (author's transl)]. / Complications urinaire et vasculaire d'une tumeur digestive. Aspect clinique et problèmes thérapeutiques

In a 25-year-old woman presenting with a right ureteric stenosis, the authors had the surprise to find at operation an extensive tumour of the small intestine. The tumour compressed the ureter and involved the common iliac, artery, requiring a complex surgical procedure with major vessel repair.