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E Neidhardt

Publications and source records attributed to E Neidhardt.

7 recordsLinked to original sources
PubMed2005

In vitro evaluation of B-domain deleted recombinant factor VIII (ReFacto) stability during simulated continuous infusion administration.

The administration of factor VIII (FVIII) by continuous infusion (CI) to manage severe haemorrhage or during major surgery appears pharmacokinetically and economically favourable when compared with intermittent bolus infusions. Successful clinical use of FVIII delivered by CI, however, requires a thorough assessment of product stability under conditions encountered during CI such as prolonged exposure to the delivery devices at ambient temperature and the low FVIII concentrations. This investigation has identified conditions under which ReFacto, a recombinant human B-domain deleted FVIII, can be successfully delivered under dilute conditions when using large volume parenteral polyvinyl chloride (PVC) bags without the addition of stabilizers or as an undiluted preparation delivered by ambulatory infusion pumps. ReFacto is stable for 36 h when stored in large volume parenteral PVC reservoirs at 3 and 8 IU mL(-1) or 72 h when delivered undiluted at 62 IU mL(-1) by CADD infusion pumps. The greatest concern with the delivery of ReFacto by CI is adsorptive losses to the contact surfaces of the delivery system. There was no significant binding of ReFacto to the PVC reservoirs overtime; however, there was appreciable binding to the administration set under certain conditions. The binding was influenced by the ionic strength of the solution, residence time in the tubing and protein concentration. The recovery and stability profile of ReFacto under certain conditions appears favourable when compared with that of full-length recombinant FVIII products, observed by other investigators.

Adsorption↗
PubMed2001

B-domain deleted recombinant factor VIII formulation and stability.

B-domain deleted recombinant factor VIII (BDDrFVIII) is a deletion form of human coagulation factor VIII. A lyophilized formulation of highly purified BDDrFVIII has been developed that does not require the use of blood-derived products such as human serum albumin (HSA). By avoiding the use of blood-derived products, the BDDrFVIII formulation minimizes the risk of transmitting blood-borne pathogens that may be present in plasma-derived factor VIII or in other recombinant factor VIII products that contain HSA in their formulation. Upon reconstitution with saline (4 mL), the composition of the reconstituted product (62.5 to 250 IU/mL BDDrFVIII) is 18 mg/mL sodium chloride, 3.0 mg/mL sucrose, 1.5 mg/mL L-histidine, 0.25 mg/mL calcium chloride dihydrate, and 0.1 mg/mL polysorbate 80. The optimal combination of these excipients in the lyophilized BDDrFVIII formulation provides long-term stability, as measured by a variety of analytical methods. The formulation preserves factor VIII activity of lyophilized BDDrFVIII during storage for at least 24 months at 8 degrees C, and for up to 6 months at room temperature (25 degrees C). The reconstituted product retains its factor VIII potency for at least 100 hours at 25 degrees C, which would allow it to be continuously administered via an infusion pump, assuming the product is handled under aseptic conditions.

Consumer Product Safety↗
PubMed1998

Do patients with panic disorder show a memory bias?

BACKGROUND: Cognitive models of panic disorder are becoming more and more influential. Therefore, research specifying cognitive processes related to panic disorder is needed. The present study investigated memory bias for panic-related material in patients with panic disorder. METHODS: Memory bias for panic-related material was investigated experimentally by a memory task requiring classification of panic-related and non-panic-related words. Sixty patients with panic disorder and 60 controls with no diagnosis of a mental disorder participated in the study. RESULTS: As expected, panic patients showed smaller differences in the time needed for classification of panic-related versus non-panic-related material than controls. CONCLUSIONS: Patients with panic disorder show a memory bias for panic-related material when conceptual implicit recall is required. In order to clarify whether this bias is involved in the maintenance of the disorder, it seems important to investigate whether the bias is still present after successful therapy.

Adolescent↗
PubMedDate not supplied

Memory bias for panic-related material in patients with panic disorder.

Two experiments investigated memory bias for panic-related material in 40 patients with panic disorder and 40 healthy control subjects. No memory bias was found on a memory task that tested intentional encoding and explicit recall of panic-related versus non-panic-related sentences. In contrast, a significant memory bias was apparent on a memory task requiring classification of panic-related and non-panic-related words to test conceptual information processing in implicit memory. Panic patients learned panic-related material better than controls.

Adolescent↗
PubMedDate not supplied

[Age differences versus aging--a cross-sectional and longitudinal analysis on the development of memory in advanced age].

This study examines the development of episodic memory in later adulthood and old age in a combined cross-sectional and longitudinal design. 124 normal aging subjects, aged 50-87 years, representing four age groups (M1 = 53.65 years, M2 = 60.60 years, M3 = 68.44 years, M4 = 75.83 years) participated in a cross-sectional study. Seven years later a retest was done in which 70% of the original sample again participated. Significant differences between the cross-sectional and the longitudinal results were found, with the latter showing the more severe decline in memory performances. Moreover, the age decline occurred earlier in the longitudinal study. Cohort differences account for these differences between the cross-sectional and longitudinal findings, favoring subjects of earlier-born cohorts.

Aged↗