[Biochemical markers in clinical trials for NDA of anti-osteoporotic drugs].
Alendronate expecting new drug registration soon is the first anti-osteoporotic drug fully utilizing biochemical markers in clinical trials for NDA. In clinical trials of anti-osteoporotic drugs being on the market in Japan only classical biochemical markers were measured. The effects to new biochemical markers should be checked in post-marketing studies. So far bone resorption markers have been extensively studied because present anti-osteoporotic drugs are anti-bone-resorption type. From now progress of bone formation markers is expected along with studies of bone forming type anti-osteoporotic drugs.
Mizuno
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Tokyo CRO Inc.