[Recommendations of the German Society for Clinical Chemistry. Performance of clinico-chemical tests on pharmaceuticals (revised version 1984)].
Since the results from animal experiments are of only limited value for the interpretation of the human response to pharmaceuticals, it is essential that clinical-chemical studies should be very carefully planned. The German Society for Clinical Chemistry has therefore summarized the body of collective experience in the testing of pharmaceuticals. The following recommendations should also ensure that accuracy and interpretative value of the results from different investigators are comparable. The recommendations also contain a programme for the investigation of body functions using clinical-chemical tests. Additional tests are necessary for the assessment of some pharmaceutical preparations. In certain cases a more restricted type of investigation may be sufficient depending on the stage of testing.
D001774:Blood Chemical Analysis; D002624:Chemistry, Clinical / Q000639:trends*; D002626:Chemistry, Pharmaceutical; D004798:Enzymes / Q000097:blood; D005860:Germany, West; D006801:Humans; D011786:Quality Control
D004798:Enzymes
Empfehlungen der Deutschen Gesellschaft für Klinische Chemie zur Durchführung klinisch-chemischer Untersuchungen bei der Prüfung von Arzneimitteln. Uberarbeitete Fassung 1984.