溶出与吸收近来美国FDA提出的新产品生物利用度试验,要求供试品的相对生物利用度在75％的个体内不低于已经临床验证的参考药物的75％。Haynes批评了该75/75要求,其理由是满足该要求的新产品概率与生物利用度的个体差异有关。为此推荐了另一种统计试验法。人体口服10种乌洛托品制剂,发现其分解产物甲醛在尿中的浓度差异很大; Dissolution and Absorption Recent bioavailability tests of new products proposed by the U.S. FDA require that the relative bioavailability of the test product be no less than 75% of the clinically validated reference drug in 75% of individuals. Haynes criticized this 75/75 requirement on the grounds that the probability of new products meeting this requirement is related to individual differences in bioavailability. To this end recommended another statistical test. Oral 10 kinds of urotropine preparations, found that the decomposition of formaldehyde in urine concentrations vary widely;