Relationship between receiving authorities and monitoring authorities. The EMEA experience.

The approach of the European Medicines Agency (EMEA) to good laboratory practice (GLP) inspections in the context of authorization of medicinal products is illustrated with particular reference to the EMEA's experience as a receiving authority (RA), the procedures it has in place for the reporting and follow-up of GLP inspections, and the role of the ad hoc GLP inspectors working group. Other key issues dealt with are the relationship between the EU monitoring authorities (MAs) and the EMEA as a specific RA, how inspections outside the EU are handled and some aspects (exchange of information, handling of non-compliance, triggers for inspection) that have been raised during recent inspections.

Surgical treatment for acute spinal cord injury study pilot study #2: evaluation of protocol for decompressive surgery within 8 hours of injury.

Acute spinal cord injury (SCI) is a major public health problem for which there is still only limited treatment available. The National Acute Spinal Cord Injury Study-2 (NASCIS-2) and -3 clinical trials demonstrated that the use of acute pharmacotherapy with methylprednisolone can attenuate the secondary injury cascade if administered within 8 hours of acute SCI. However, no trial has been performed to examine whether acute surgical decompressive procedures within this critical 8-hour time window can improve patients' neurological outcome.

The optimal radiologic method for assessing spinal canal compromise and cord compression in patients with cervical spinal cord injury. Part II: Results of a multicenter study.

Study Design: A multicenter, retrospective study using computed tomographic and magnetic resonance imaging data to establish quantitative, reliable criteria of canal compromise and cord compression in patients with cervical spinal cord injury.

Objectives: To develop and validate a radiologic assessment tool of spinal canal compromise and cord compression in cervical spinal cord injury for use in clinical trials.

Summary Of Background Data: There are few quantitative, reliable criteria for radiologic measurement of cervical spinal canal compromise or cord compression after acute spinal cord injury.

Variation in surgical opinion regarding management of selected cervical spine injuries. A preliminary study.

Study Design: The opinions of orthopedic surgeons and neurosurgeons were compared regarding appropriate management of selected cervical injuries and the timing of stabilization.

Objective: To determine whether there is consistency of opinion regarding the management of cervical trauma.

Summary Of Background Data: Numerous forms of management for cervical trauma exist, but there are few consistent recommendations.

Continuous intrathecal meperidine via an implantable infusion pump for chronic, nonmalignant pain.

Objective: To report a continuous infusion of intrathecal meperidine via an implanted infusion pump for nonmalignant, chronic pain.

Case Summary: A 69-year-old white woman had chronic, nonmalignant low-back pain and bilateral leg pain. Multiple drug therapies and other interventional techniques had failed.

Retropharyngeal pseudomeningocele after atlanto-occipital dislocation: report of two cases.

Objective And Importance: We report two cases of retropharyngeal pseudomeningocele after atlanto-occipital dislocation. This is rare, with only one other reported case in the literature.

Clinical Presentation: We report two patients who presented after blunt cervical and head trauma.

Fusion rate and biomechanical stiffness of hydroxylapatite versus autogenous bone grafts for anterior discectomy. An in vivo animal study.

Study Design: The fusion rate and biomechanical stiffness were evaluated for 56 goat spinal units from 14 animals that had anterior discectomies and grafting procedures completed using hydroxylapatite and autogenous bone and survived for 6, 12, and 24 week healing times.

Objectives: Harvested spinal units underwent radiographic imaging to assess fusion, biomechanical testing in axial compression, flexion, extension, lateral bending, and axial rotation to assess strength, and histological analysis. The above results were compared for the two procedures and the different healing times.

Determination of Kupffer cell Fc receptor function in vivo following injury.

This study was carried out to determine whether Kupffer cell Fc receptor function is depressed after injury. Three approaches to the determination of Fc receptor function were evaluated: IgG-coated erythrocytes (EIgG) were used as the receptor probe with a perfused liver system, EIgG were used as the receptor probe in vivo, and small aggregates of IgG (AIgG) were used as the receptor probe in vivo. Nearly half of the injected dose of EIgG was taken up by the perfused liver (nonrecirculating, serum-free system).

Hepatic macrophage complement receptor clearance function following injury.

Previous work has demonstrated that in vivo hepatic macrophage complement receptor clearance function is depressed following thermal injury. The present study was carried out to determine if complement receptor function depression is associated with other states of depressed host defense. Hepatic complement receptor clearance function was determined from the hepatic uptake of rat erythrocytes coated with antierythrocyte IgM (EIgM) in rats.

Depression of in vivo clearance function of hepatic macrophage complement receptors following thermal injury.

Previous studies have implicated a role for impaired hepatic macrophage blood clearance function in the increased susceptibility to infection caused by experimental thermal injury. The present study evaluated in vivo hepatic macrophage complement receptor clearance function as a possible factor contributing to impaired hepatic clearance after thermal injury. Rat erythrocytes treated with anti-erythrocyte serum (EA) were used as the test particle in rats.