New model for simulation of fracture repair in full-grown beagle dogs: model characterization and results from a long-term study with ibandronate.

Introduction: Given that bisphosphonates reduce bone turnover, it is important to establish that their long-term administration does not impair bone quality. This paper describes a new model for simulation of fracture repair to evaluate several aspects of bone quality following long-term administration (34 or 36 weeks) of ibandronate in full-grown beagle dogs.

Methods: The treatment schedule consisted of continuous daily subcutaneous administration of a pharmacologically active dose (1 microg/kg/day) and two cyclical intermittent regimens providing a similar total dose per animal at the end of the experiment.

[Animal experiments in the context of quality control of pharmaceuticals. Review of the European Pharmacopoeia, 4th edition, 2002].

In the 4th edition of the European Pharmacopoeia, animal experiments are described, which are required for the quality control of pharmaceuticals. This refers to investigations regarding both biological activity and safety aspects of the medication. The latter include investigations to find contaminations with histamine and pyrogenic substances and tests for abnormal toxicity.

Prevention of cold-preservation injury of cultured endothelial cells by catecholamines and related compounds.

The present study was conducted to dissect the underlying mechanisms by which catecholamines protect cells against preservation injury. To this end, we firstly defined the cellular and molecular differences between protected and nonprotected cells and secondly defined the mediators that were involved in cold-induced damage. Cold storage of untreated human umbilical vein endothelial cells (HUVECs) resulted in profound cellular damage as assessed by lactate dehydrogenase (LDH) release and by morphological changes, e.

[The development and approval of alternative methods to bioassays used for quality assurance, a challenge for the pharmaceutical industry and the authorities].

Bioassays are performed to ensure a constant quality of medicines derived from biological sources. These tests are stipulated for some drugs in the German and European Pharmacopoeias. They are justified because physico-chemical or other analytical methods may not be appropriate to define exactly the potency of the drug in each individual batch and/or to detect any biologically relevant impurities.