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r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial

2010-07-15 17:00:00 | BioPortfolio

Summary

The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg, 8.8 mg/1.51 mL) as reference.

Each volunteer received three r hGH treatments, with each treatment being administered as a single subcutaneous dose of 4 mg r-hGH in a randomized sequence with at least one week of wash-out period between successive treatments.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Growth Failure

Intervention

r-hGH liquid (Saizen), r-hGH liquid (Saizen), r-hGH freeze-dried

Location

AAI Pharma Deutschland GmbH & Co. KG
Neu-Ulm
Germany

Status

Completed

Source

EMD Serono

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Medical and Biotech [MESH] Definitions

The removal of a soluble component from a liquid mixture by contact with a second liquid, immiscible with the carrier liquid, in which the component is preferentially soluble. (McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed)

Miniaturized methods of liquid-liquid extraction.

A replica technique in which cells are frozen to a very low temperature and cracked with a knife blade to expose the interior surfaces of the cells or cell membranes. The cracked cell surfaces are then freeze-dried to expose their constituents. The surfaces are now ready for shadowing to be viewed using an electron microscope. This method differs from freeze-fracturing in that no cryoprotectant is used and, thus, allows for the sublimation of water during the freeze-drying process to etch the surfaces.

A method of separation of two or more substances by repeated distribution between two immiscible liquid phases that move past each other in opposite directions. It is a form of liquid-liquid chromatography. (Stedman, 25th ed)

Chromatographic techniques in which the mobile phase is a liquid.

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