正文
c
）血液样品收集。
(1) When comparison of the test product and the reference material is to be based on blood concentration time curves, unless some other approach is more appropriate for valid scientific reasons, blood samples should be taken with sufficient frequency to permit an estimate of both:
（
1
）当测试样品与参比
制剂
进行比较时，以血药浓度
-
时间曲线为基础，除非有其他更合适有效的科学
依据
，否则应以足够的频率采集血液样品，以便对二者进行评估。
(i) The peak concentration in the blood of the active drug ingredient or therapeutic moiety, or its metabolite(s), measured; and
（
i
）测定活性药物成分或治疗结构或其代谢物在血液中峰浓度；和
(ii) The total area under the curve for a time period at least three times the half-life of the active drug ingredient or therapeutic moiety, or its metabolite(s), measured.
（
ii
）至少测定药物活性成分或治疗结构或其代谢产物半衰期的三倍时间的曲线下总面积。
(2) In a study comparing oral dosage forms, the sampling times should be identical.
（
2
）在比较口服剂型时，取样时间应相同。
(3) In a study comparing an intravenous dosage form and an oral dosage form, the sampling times should be those needed to describe both:
（
3
）在比较静脉注射剂型和口服剂型时，取样时间应满足二者的需要。
(i) The distribution and elimination phase of the intravenous dosage form; and
（
i
）静脉注射剂型的分布和消除阶段；和
(ii) The absorption and elimination phase of the oral dosage form.
（
ii
）口服剂型的吸收和消除阶段。
(4) In a study comparing drug delivery systems other than oral or intravenous dosage forms with an appropriate reference standard, the sampling times should be based on valid scientific reasons.
（
4
）在比较
有
适当
参比制剂、
口服或静脉注射剂型以外
给药方式
的研究中，取样时间应
按照
有效的科学依据。
(d) Collection of urine samples. When comparison of the test product and the reference material is to be based on cumulative urinary excretion-time curves, unless some other approach is more appropriate for valid scientific reasons, samples of the urine should be collected with sufficient frequency to permit an estimate of the rate and extent of urinary excretion of the active drug ingredient or therapeutic moiety, or its metabolite(s), measured.
（
d
）尿样收集。当测试产品和参比
制剂
的比较是基于尿药累积排泄量曲线时，除非有其他更合适的有效的科学
依据
，否则应以足够的频率收集尿样，以便对活性药物成分或治疗结构或其代谢产物的尿液排泄率和
排泄量
进行估计。
(e) Measurement of an acute pharmacological effect.
（
e
）急性药理作用的测定
(1) When comparison of the test product and the reference material is to be based on acute pharmacological effect-time curves, measurements of this effect should be made with sufficient frequency to permit a reasonable estimate of the total area under the curve for a time period at least three times the half-life of decay of the pharmacological effect, unless some other approach is more appropriate for valid scientific reasons.
（
1
）当试验产品和参比
制剂
