Class of 2012 Abstract / Objectives: The primary objective of this study was to evaluate the appropriateness of when aminoglycoside serum concentrations are obtained and assess whether the timing and techniques used in obtaining aminoglycoside serum concentrations are appropriate. Additionally, pharmacists’ interpretation of aminoglycoside serum concentrations and the appropriateness of intervention in response to these results were assessed. Methods: This descriptive retrospective study to evaluate the appropriateness of aminoglycoside monitoring at an academic medical center has been approved by the Institutional Review Board. Patients over the age of 46 weeks gestational age admitted to an academic medical center between February 1, 2010 to February 1, 2011 who were prescribed intravenous aminoglycoside therapy were included in this study. Patients with therapy duration of less than 72 hours without at least one aminoglycoside level were excluded. The time of aminoglycoside concentrations in relation to time of aminoglycoside administration along with calculated pharmacokinetic parameters and therapy recommendations documented in clinical notes were also recorded. Appropriateness of aminoglycoside monitoring and documentation were determined by use of expert opinion and pharmacokinetic guidelines. Results: Timing of aminoglycoside serum concentrations and subsequent clinical assessments were evaluated in 103 subjects. The median (range) age was 28 (0.2 – 88) years. The initial aminoglycoside prescribed in 12%, 40%, and 48% of subjects was amikacin, gentamicin, and tobramycin, respectively. A total of 314 aminoglycoside concentrations were obtained: 41 amikacin, 129 gentamicin, and 144 tobramycin. At least one clinical pharmacokinetic assessment of aminoglycoside concentration(s) was written for 91 subjects (88%). The aminoglycoside indication, actual time of aminoglycoside dose administration, estimated renal function, and both goal peak/trough aminoglycoside concentrations were documented in at least one aminoglycoside clinical note for each of these 91 subjects at a rate of 95%, 80%, 89%, and 51%, respectively. Calculated peak, trough, estimated volume of distribution, and estimated half-life or ke were documented in 53 subjects. Conclusions: Aminoglycoside serum concentration monitoring can be used to maximize therapeutic outcomes while minimizing toxicity. However, errors in obtaining and evaluating serum drug levels can arise that may affect patient outcomes. For monitoring to be effective, the timing of serum concentration orders, the process of obtaining serum concentration samples, and the interpretation of data including pharmacokinetic calculations should be accurate.

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Experimental vaccines have been made by covalently bonding virus particles into polymerized rabbit serum albumin beads. Using Nodamura virus as a model antigen, these model vaccines induced specific humoral antibody production, comparable with that achieved using Freund's adjuvants. Virus specific antibodies were also induced when Nodamura virus was covalently attached to the bead surface using different crosslinkers. However, when poliovirus type 2 (Sabin strain) was polymerized into beads, the levels of neutralizing antibodies were insignificant compared with control aqueous vaccines. The synthetic immunostimulator, muramyl dipeptide, was included with bead vaccines in an attempt to potentiate the immune response. Immunostimulation is achieved by a slow release of antigen coinciding with the gradual breakdown of bead structure.

Lee, T. et al (1981) proposed the encapsulation of hormones such as progesterone into serum albumin beads, such that their in vivo proteolysis would allow a gradual release of hormone at low levels, for extended hormone action. It was proposed, in the Department of Microbiology, Rhodes University, to replace the hormone component of the above bead formulation, with virus as antigen, in the development of a vaccine. Beads optimally crosslinked at 1% final glutaraldehyde concentration, containing Nodamura virus, were shown to promote an adjuvant effect in vivo, analogous to the release of antigen from Freund's Complete Adjuvant (FCA), so that extended immunostimulation resulted. It was shown that soluble antigen promoted a short-lived primary immune response, peaking around day 25 following inoculation. Antigen presented in beads, on the other hand, initially elicited a low humoral response, but this response gradually increased up to a peak around day 110 post inoculation, before decreasing. No apparent adverse side-effects were noted following inoculation of antigen-containing serum albumin beads, compared to necrosis following antigen in FCA inoculation, supporting the proposal of using albumin homotypic for the test inoculee animal, so that the beads would themselves be non-immunogenic and would merely act as a vehicle in the vaccine formulation. The indirect enzyme-linked immunosorbent assay (ELISA) was used to monitor the humoral response to antigen following inoculation. Results showed that covalent crosslinking of albumin in the formation of the beads did not promote immunogenicity on the part of the chemically altered albumin. The ELISA test was used to indicate the kinetics of the IgG response to Nodamura virus when presented in formulations such as: Freely soluble virus or its subunit; soluble intact virus inactivated by treatment with glutaraldehyde; intact virus entrapped in serum albumin beads cross; linked at different percentage final glutaraldehyde concentrations and also virus subunit prepared in albumin beads. The presence of virus-neutral ising antibodies was noted in serum obtained from rabbits inoculated with virus entrapped in albumin beads. Virus infectivity, titrated in mice, showed protection against virus challenge after incubation of virus with serum obtained above.

A Thesis Submitted to the Faculty of Science University of the Witwatersrand, Johannesburg for the Degree of Doctor of Philosophy Johannesburg 1976 / This thesis describes the results of experimental investigation of aspects of the endocrine regulation of growth in the rabbit, rat and man. In particular the role of serum somatomedin and cartilage responsiveness to somatomedin have been examined. Throughout a relationship between the physiological control mechanisms, namely the stimulus and the degree of end- organ responsiveness, and the velocity of growth has been sought. / IT2017

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