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生物利用度的含义近年来,含有相同主药的各种制剂愈来愈多,这些制剂的处方或工艺过程并不相同,因此有必要考虑它们的临床疗效有无明显差异,这些差异的本质是什么?哪些因素可引起这些差异?怎样评价?在这方面采用什么标准去选择? 按理想,为保证不同批号药品的疗效相同,就须每批抽样直接在临床上评定疗效。但由于临床试验需要许多病情相同的患者,过程复杂,代价很高,且很多客观检查方法不灵敏或根本没有,因此在实际上是有困难的。
The meaning of bioavailability In recent years, more and more formulations containing the same main drug, these formulations are not the same prescription or process, it is necessary to consider whether there are significant differences in their clinical efficacy, the essence of these differences is What factors can cause these differences? How to evaluate? In this regard what criteria to choose? Ideally, in order to ensure the same efficacy of different batches of drugs, each batch of samples must be directly assessed in clinical efficacy. However, since clinical trials require many patients with the same disease, the process is complex, expensive, and many objective tests are not sensitive or non-existent, they are actually difficult.