Biomedical subjects

M Holz-Slomczyk

Publications and source records attributed to M Holz-Slomczyk.

3 recordsLinked to original sources

PubMed1998

When are bioavailability studies required? A German proposal.

The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), the German drug regulation authority, issued guidelines for determining whether bioavailability/bioequivalence studies are required for certain drugs. This decision tree is based on pharmacodynamic, pharmacokinetic, and physicochemical criteria. Details of this decision tree were worked out by an expert panel, the Bioavailability Commission at the BfArM. The decision tree has been in use by German regulatory authorities for more than 10 years. In the meantime, its essentials were adopted by the European Committee for Proprietary Medicinal Products (CPMP) and by the World Health Organization (WHO) for their "Guidelines on interchangeability of multisource pharmaceutical products." This article reviews the original decision tree of the BfArM and provides examples of drugs that have been assessed according to its rules. The current procedure of the German regulatory authorities for judging the necessity of bioavailability trials, which reflects the status quo of regulatory practice in Germany, is also discussed.

Biological Availability↗

PubMed1978

[Reye's syndrome in adults (author's transl)].

The clinical picture of Reye's syndrome, characterized by an acute severe disease of brain and liver, initially has nonspecific generalized symptoms with cough, myalgia, and fever. The prognosis is poor. The disease starts with an infection, quickly followed by vomiting and loss of consciousness. In this phase the serum bilirubin is moderately raised, the transaminases markedly so. In addition to gastro-intestinal bleeding there may be hypoventilation, hypoglycaemia and seizures. Morbid anatomically there is a small-drop fatty infiltration of the liver and other organs with cerebral oedema. Aetiology and pathogenesis remain uncertain. Numerous therapeutic measures have been proposed.

Adult↗

PubMed1975

Studies of liver function and structure in patients with gallstones before and during treatment with chenodeoxycholic acid.

Twelve patients with gallstones were treated with chenodeoxycholic acid (CDCA) for 3 to 22 months. Liver function and structure were studied before and during treatment. No signs of hepatotoxicity were observed. Activities of several enzymes, including transaminases, GLDH, and gamma-GT were frequently abnormal in this group of patients. But there was no statistical difference between treatment and pre-treatment levels. Serum bilirubin and protein electrophoresis remained normal throughout the study. The BSP retention test was not significantly altered by CDCA treatment. Light microscopic examination in 8 patients revealed no changes of liver structure during 3 to 19 months of CDCA administration except, however, for a decrease of fatty changes in 3 patients. The ultrastructure of liver cells was found to be normal in 5 patients, in whom electron microscopy was done as well.

Adult↗