Roger G. Stoll

Pharmacokinetics of Hydroxyethyl Starch in Normal Subjects

Abstract: To determine the elimination of high‐molecular‐weight hydroxyethyl starch (HES, Mw 450,000) in normal subjects, ten volunteers were given 500 ml 6% HES solution by intravenous infusion, and serial blood and urine samples were collected for nonglucose total carbohydrate determination. On the average, 46 and 64 per cent of the dose was excreted in the urine within two and eight days, respectively. The plasma concentration declined rapidly during the first week after infusion. The average terminal half‐life was 17 days during the first 42 days, which accounted for elimination of about 90 per cent of the dose. The remainder was eliminated with a terminal half‐life of 48 days determined between days 42 and 83 of the study. As expected, the infusion of HES resulted in plasma volume expansion over a 48‐hour period during which time levels of nonglucose carbohydrates were above 3.5 mg/ml. HES is metabolized by α‐amylase in the body. During the first 48 hours after infusion of HES, plasma α‐amylase activity was significantly increased over control. Concomitantly, α‐amylase activity in urine was also elevated but not significantly so.

Organization Within the Pharmaceutical Industry - a Survey

AbstractA survey has been made of 12 U.S. and 5 U.K. companies in order to establish if there are any favored organizational structures in terms of pilot plant and related operations, production trouble shooting, clinical supplies manufacture and general engineering support services. Broad patterns of behavior become apparent in terms of the manner in which companies organize themselves to perform these functions. Communication, background and training of personnel and well-drawn lines of responsibility emerge as important factors in the efficient operation of the organizations surveyed.This survey was undertaken in order to establish if there are any favored organizational structures in terms of pilot plant and related operations, production trouble shooting, clinical supplies manufacture, and general engineering support services. Senior Research and Development and Manufacturing personnel in 12 U.S. and 5 U.K. companies were contacted individually and asked to participate. The confidentiality of the sur...