[Recommendations of the German Society for Clinical Chemistry. Performance of clinical-chemical tests on pharmaceuticals (author's transl)].
In the Federal Republic of Germany, the recommendations of professional bodies for the testing of pharmaceuticals, which were published rather a long time ago, do not refer to clinical-chemical investigations (Report of the executive committee of the German Pharmacological Society and the Commission for the establishment of guide lines for the testing of pharmaceuticals, Naunyn-Schmiedeberg's Arch. Exp. Pathol. Pharmakol 245 (1963) Supplement p. 20; and Report of the Executive Committee of the German Society for Internal Medicine for the establishment of guide lines for clinical testing of pharmaceuticals, e.g. Klin. Wochenschr. 43,698 (1965)). 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 guide lines should also ensure that the accuracy and interpretive value of the results from different investigators are comparable. The recommendations also contain a program for the clinical chemical investigation of body functions. Additional tests are necessary for the assessment of many pharmaceutical preparations. In certain cases (e.g. topical application), a more restricted type of investigation may be sufficient at a later stage of testing.
D002624:Chemistry, Clinical; D002986:Clinical Trials as Topic; D004341:Drug Evaluation / Q000592:standards*; D005860:Germany, West; D006801:Humans; D012957:Societies, Pharmaceutical
Empfehlungen der Deutschen Gesellschaft für Klinische Chemie zur Durchführung klinisch-chemischer Untersuchungen bei der Prüfung von Arzneimitteln