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[德国临床化学学会的建议。药物临床化学检测的性能(1984年修订版)]

[Recommendations of the German Society for Clinical Chemistry. Performance of clinico-chemical tests on pharmaceuticals (revised version 1984)].

出版信息

J Clin Chem Clin Biochem. 1984 Nov;22(11):811-5.

PMID:6527098
Abstract

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.

摘要

由于动物实验结果对于解释人类对药物的反应仅有有限的价值,因此临床化学研究必须精心规划。德国临床化学协会因此总结了药物测试方面的集体经验。以下建议还应确保不同研究者的结果的准确性和解释价值具有可比性。这些建议还包含一个使用临床化学测试来研究身体功能的方案。对于某些药物制剂的评估,还需要进行额外的测试。在某些情况下,根据测试阶段,更有限的调查类型可能就足够了。

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