Is self-sufficiency financially viable and ethically justifiable?--a commercial viewpoint.

Manufacturers of blood products have to maintain the highest possible standards for plasma screening and good manufacturing practices to ensure maximum purity and viral safety. The private sector companies have much experience in implementing and complying with national and international regulations. These requirements involve considerable cost in the areas of (1) plasma collection facilities, (2) research and clinical research, (3) manufacture, and (4) quality control. Total self-sufficiency would mean the loss of many existing resources. An alternative would be a collaboration between the public and private sectors to meet the needs of all patients who require plasma derived products. The current definition of self-sufficiency suggests that it is not financially viable.

Comparison of the pharmacokinetics of porcine calcitonin in saline and in gelatin diluents in healthy volunteers.

A randomised 2-way crossover study was carried out in nine healthy male volunteers to compare the pharmacokinetics of porcine calcitonin (pCT) following i.m. administration of 160 i.u. of pCT in physiological saline or in a solution of hydrolysed gelatin. A new radioimmunoassay for pCT is described. It employs an antiserum raised in a guinea pig and a labelled tracer prepared from highly purified pCT. While comparable mean areas under the serum concentration-time curve for both dosage forms indicate equivalent bioavailability, the serum pCT profiles were different; peak pCT levels of 8.3 +/- 0.8 ng ml-1 (s.e.m.) occurred at 13 +/- 2 min (s.e.m.) with peak levels of 4.8 +/- 0.5 ng ml-1 (s.e.m.) when the gelatin diluent was used. The hypocalcaemic effects produced by the two preparations of pCT were of short duration (less than 1 h) and of a similar magnitude (-0.08 to -0.12 mmol.l-1). Comparable degrees of hypophosphataemia (-0.11 to -0.15 mmol.l-1) were observed 20 min post-injection. The administration of pCT in gelatin and saline diluents resulted in markedly different pharmacokinetic profiles. Whether there are therapeutic advantages in the use of either diluent remains to be investigated.

Pharmacokinetics of an oral frusemide/amiloride combination tablet.

A randomized four-way crossover study was carried out in 12 healthy volunteers to investigate the pharmacokinetics of a new oral combination of frusemide (40 mg) and amiloride (5 mg), formulated as a single tablet. The experimental design of this bioequivalence study used commercially-available 40 mg frusemide tablets and 5 mg amiloride tablets as reference drugs, administered either separately or concomitantly. From a statistical analysis of plasma levels of frusemide and amiloride, no significant differences between the reference drugs alone and the combination tablet were seen in peak plasma levels, mean times to peak or mean areas under the plasma concentration-time curves (AUCs). The ratio of AUCs of the combination tablet to the reference drugs approached a limiting value many hours prior to complete elimination of the drug and hence reliable bioavailability comparisons were possible with blood sampling up to 24 hours post-dose.