Publications by authors named "Haby T"

Public lands worldwide provide diverse resources, uses, and values, ranging from wilderness to extractive uses. Decision-making on public lands is complex as a result and is required by law to be informed by science. However, public land managers may not always have the science they need.

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Understanding the structure and composition of landscapes can empower agencies to effectively manage public lands for multiple uses while sustaining land health. Many landscape metrics exist, but they are not often used in public land decision-making. Our objectives were to (1) develop and (2) apply a process for identifying a core set of indicators that public land managers can use to understand landscape-level resource patterns on and around public lands.

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H Time-Domain Nuclear Magnetic Resonance (TD-NMR) is used to characterize solutions of antibodies that simulate biologic pharmaceutical formulations. The results from these measurements are compared with those from solutions in which the concentration or identity of the antibody has been altered. TD-NMR is shown to be very sensitive to differences in the amount of antibody in solution, with the ability to detect variations in as low as 2 mg/mL.

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Monoclonal antibodies (mAb) are being widely studied for the treatment of cancers and other diseases. The mAb is typically in a solution formulation and administered as an intravenous infusion. Ready-to-use solutions are favored for their clinical convenience but they can potentially suffer from a shorter shelf life due to accelerated rates of some forms of degradation such as oxidation, relative to lyophilized formulations.

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Five commonly used stopper formulations were tested for extractables using three different vehicles (pH 3 citrate buffer with 20% w/v sulfobutylether-beta-cyclodextrin, pH 8 phosphate buffer and 50/50 v/v polyoxyethylated castor oil/dehydrated alcohol). The stoppers, made from butyl and halobutyl rubbers, coated and uncoated with proprietary films, were stored in contact with each vehicle for up to 6 months at 40 degrees C/75% relative humidity (RH) or for up to 24 months at 25 degrees C/60% RH. Samples were analyzed for the presence of extractables using inductively coupled plasma-atomic emission spectroscopy, ion chromatography, high-performance liquid chromatography, and gas chromatography.

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To develop a rational approach for the formulation of lyophilized products, six bulking agents commonly used in freeze-dried formulations were lyophilized under identical conditions, and their moisture sorption behavior, before and after lyophilization, were determined as a function of relative humidity at 25 degrees C. The bulking agents evaluated were mannitol, anhydrous lactose, sucrose, D(+)-trehalose, dextran 40 and povidone (PVP K24). The materials were also characterized for their crystal and thermal properties by powder X-ray diffraction, DSC and TG after exposure to various relative humidity conditions.

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The interaction between different components used in the preparation of a new radiodiagnostic agent, BMS-181321, was overcome by its lyophilization as a bilayered product. BMS-181321 is composed of a nitroimidazole ligand BMS-181032, that is complexed with technetium-99m just before it is used in radionuclide imaging studies. Stannous chloride is required to reduce technetium from the +7 to the +5 oxidation state before it can be complexed by the ligand.

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As part of a commitment to fully automate the manufacture of a lyophilized dosage form of Azactam (Aztreonam for Injection), an automated solution batching procedure was developed. The lyophilization process requires solution batching of Aztreonam and L-arginine, the two constituents of the product. To avoid preblending of aztreonam and L-arginine prior to dissolution, a batching process was developed which makes use of two separate volumetric powder feeders.

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