最后强调了生物等效性研究对于化学药物和生物制品的同等重要性。
We emphasized in the conclusion that the bioequivalence study for chemical drugs is as important as for biological products.
目的:对国产盐酸氨溴索口腔崩解片和进口普通片进行生物等效性研究。
OBJECTIVE To study the bioequivalence of ambroxol hydrochloride orally disintegrating tablets in Chinese healthy volunteers.
应综述在临床安全性和有效性,生物利用度研究或生物等效性研究中所用到的所有配方。
A summary of formulations used in clinical safety and efficacy and in any relevant bioavailability or bioequivalence studies should be provided.
我们在积极推动这些产品,无论是通过制定开展生物等效性研究的指南,还是通过实施资格预审规划。
We aggressively promote them, whether through guidelines for conducting bioequivalence studies or through the prequalification programme.
目的研究缬沙坦胶囊生物等效性。
OBJECTIVE To study the bioequivalence of domestic and imported valsartan capsule.
目的研究2种盐酸左氧氟沙星胶囊的人体生物等效性。
OBJECTIVE To study the bioequivalence of 2 kinds of levofloxacin hydrochloride capsules.
目的:研究国产格列吡嗪片剂的生物等效性。
Objective:To study the bioequivalence of domestic and imported glipizide tablets.
目的研究复方格列吡嗪片人体生物利用度及生物等效性。
Objective To study the relative bioavailability and bioequivalence of compound glipizide in healthy volunteers.
目的研究奥美拉唑肠溶胶囊的人体相对生物利用度和生物等效性。
Objective To study the relative bioavailability and bioequivalence of omeprazole Enteric-coated capsules in healthy volunteers.
目的:研究多西环素肠溶微粒胶囊和多西环素片的人体生物等效性与药动学。
AIM: To study the bioequivalence and pharmacokinetics of doxycycline enteric-coated microsomes capsules and doxycycline tablets.
目的:研究盐酸雷尼替丁咀嚼片剂的人体药动学和生物等效性。
OBJECTIVE To study the pharmacokinetics and relative bioavailability of ranitidine hydrochloride chewable tablets in healthy volunteers.
目的:研究雷贝拉唑胶囊和片剂的药动学与相对生物利用度,评价其生物等效性。
AIM: To evaluate the bioequivalence of rabeprazole capsule and tablet by pharmacokinetics and relative biological availability in human beings.
目的研究氯雷他定胶囊与片剂的人体药动学和生物等效性。
Aim To study the pharmacokinetics and relative bioavailability of domestic loratadine capsules and tablets in healthy volunteers.
对个体生物等效性中样本容量的大小如何确定进行了研究,给出了一定条件下样本容量的计算公式。
Discuss the question about the samples in individual bioequivalence, give a method how to calculate the number of samples.
目的研究国产和进口硝苯地平控释片的药物动力学和生物等效性。
ObjectiveTo investigate the pharmacokinetics and bioequivalence of domestic and imported nifedipine controlled release tablets.
目的:研究国产克拉霉素颗粒剂和胶囊与进口片剂的生物利用度和生物等效性。
OBJECTIVE: To study the relative bioavailability and bioequivalence of domestic clarithromycin granule, capsule and imported tablet.
目的:研究盐酸克林霉素胶囊剂的生物等效性。
Objective: To study the bioequivalence of clindamycin hydrochloride capsules.
目的:研究国产阿呋唑嗪片剂的相对生物利用度并求证该制剂的生物等效性。
OBJECTIVE: to study the relative bioavailability of alfuzosin tablets in Chinesehealthy volunteers and to evaluate the bioequivalence.
目的研究苯酰甲硝唑胶囊人体生物等效性。
AIM To compare the pharmacokinetics and bioequivalence of between capsule and solution of benzoylmetronidazole.
目的:研究阿莫西林克拉维酸钾(7:1)分散片试验制剂与对照制剂的人体生物等效性。
OBJECTIVE: To study the bioequivalence of amoxicillin and clavulanate (7:1) disperse tablets tested to the reference.
第二十四条药物的临床研究包括临床试验和生物等效性试验。
Article 24 clinical study of drugs includes clinical trial and bioequivalence trial.
目的研究国产与进口鲑鱼降钙素喷鼻剂的生物等效性。
Objective to study the bioequivalence of imported and domestic of salmon calcitonin nasal spray in Chinese healthy volunteers.
目的:研究健康人口服马来酸氨氯地平滴丸后的药动学和生物等效性。
OBJECTIVE To study the pharmacokinetics of amlodipine maleate pills in human plasma.
目的研究盐酸托烷司琼胶囊的人体药动学和相对生物利用度并求证国产盐酸托烷司琼胶囊的生物等效性。
OBJECTIVE to study the pharmacokinetics and relative bioavailability of tropisetron hydrochloride capsules in healthy volunteers and to evaluate the bioequivalence.
目的:研究健康男性自愿者口服国产丙硫氧嘧啶片的人体相对生物利用度及生物等效性。
AIM: To study the pharmacokinetics and relative bioavailability of propylthiouracil tablet in Chinese healthy male volunteers.
目的:研究健康男性自愿者口服国产丙硫氧嘧啶片的人体相对生物利用度及生物等效性。
AIM: To study the pharmacokinetics and relative bioavailability of propylthiouracil tablet in Chinese healthy male volunteers.
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