[Prevalence of stages 3-5 chronic kidney disease in New Caledonia].

New Caledonia is a French territory located in the South Pacific Ocean. The prevalence rate of end-stage renal disease is nearly 3,000 per million inhabitants, making it one of the highest prevalence rates in the world. Preventing chronic kidney disease is a major public health issue.

Excipient exchange in the comparison of preparations of the same biologic made by different manufacturing processes: an exploratory study with recombinant human growth hormone (rhGH).

Demonstrations of bio-similarity between subsequent entry (follow-on) biologics and innovator's formulated drug products may depend upon methods that either remove excipients completely or allow the exchange of excipients to give equivalent formulations. Excipient exchange through dialysis is perhaps the simplest of such methods but its use has been hotly debated. This debate, in the absence of published data, has relied largely on theoretical considerations.

Thermal stability: a means to assure tertiary structure in therapeutic proteins.

To be both safe and effective, a therapeutic product must have the correct chemical structure and be free of harmful contaminants. Structure in protein therapeutic products, however, implies not only the correct sequence of amino acids (primary structure) but also the proper folding of that amino acid chain in three-dimensional space (tertiary structure). This work is part of a general strategy to develop a battery of physico-chemical methods that could give assurances of structure (and hence function) in formulated therapeutic proteins in the absence of in vivo data.

Comparative cardiac effects of milrinone and sodium nitroprusside in conscious rats.

The rat has been shown to be resistant to the inotropic action of milrinone. We compared in conscious rats, the effects of an i.v.

Delay in hearing loss following drug administration. A consistent feature of amikacin ototoxicity.

The time course of threshold increase in the VIII nerve compound action potential was studied in guinea pigs following amikacin administration at four different constant infusion rates. Despite the wide range of dosing durations required to achieve drug ototoxicity (2-24 days), the full development of both high and low frequency hearing loss was invariably found to be delayed with respect to the time of drug removal. The greatest degree of delayed hearing loss generally occurred within the first 7 days after drug removal, with smaller losses occurring during later time intervals.