AIM: To estimate the bioequivalence of 2 roxithromycin capsules.
目的:评价2种罗红霉素胶囊的生物等效性。
Aim To study the bioequivalence of oxymatrine dispersible tablets.
目的考察苦参素分散片生物等效性。
OBJETIVE: To evaluate the bioequivalence of domestic and imported tablets.
目的:评价国产曲他维林片剂的生物等效性。
OBJECTIVE To evaluate the bioequivalence of two domestic nimodipine tablets.
目的:评价两种国产尼莫地平片剂人体生物等效性。
Objective: To study the bioequivalence of clindamycin hydrochloride capsules.
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 domestic and imported glipizide tablets.
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 valsartan capsule.
目的研究缬沙坦胶囊生物等效性。
Article 24 clinical study of drugs includes clinical trial and bioequivalence trial.
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。
Objective: To evaluate the bioequivalence of two preparations of allopurinol tablets.
目的:评价两种国产别嘌醇片的生物等效性。
OBJECTIVE To study the bioequivalence of 2 kinds of levofloxacin hydrochloride capsules.
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 sample size calculation of bioequivalence test in clinical trial.
目的研究临床试验中等效性检验的样本量的计算问题。
Results of bioequivalence tests (clinical trials conducted in healthy volunteers), unless waived.
生物等效性试验结果(在健康自愿者身上进行临床试验),除非放弃要求。
Objective To evaluate the bioequivalence of cefdinir dispersion tablets and reference capsules.
评价头孢地尼分散片与参比胶囊的生物等效性。
OBJECTIVE:To compare the bioequivalence between famotidine chewing tablets and commercial tablets.
目的:比较法莫替丁咀嚼片、普通片的人体生物等效性。
AIM To compare the pharmacokinetics and bioequivalence of between capsule and solution of benzoylmetronidazole.
目的研究苯酰甲硝唑胶囊人体生物等效性。
Objective To study the relative bioavailability and bioequivalence of compound glipizide in healthy volunteers.
目的研究复方格列吡嗪片人体生物利用度及生物等效性。
Develop generic Human Pharmaceutical including pre-formulation, formulation, stability studies and bioequivalence.
开发普通药物,包括预研,研发,稳定性研究和生物测试等。
OBJECTIVE: To study the bioequivalence of amoxicillin and clavulanate (7:1) disperse tablets tested to the reference.
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 evaluate the bioequivalence of levofloxacin tablet or capsule and reference tablet in healthy volunteers.
目的:评价受试制剂盐酸左氧氟沙星片和胶囊与参比片剂人体生物等效性。
Objective To evaluate the bioequivalence of losartan potassium capsules and tablets in healthy Chinese male volunteers.
目的评价氯沙坦钾胶囊与氯沙坦钾片在中国健康成年男性志愿者中的生物等效性。
Article 25 for the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.
第二十五条申请新药注册,应当进行临床试验或者生物等效性试验。
Objective: To determine the bioequivalence of amoxicillin-clavulanate potassium (14 : 1) granules in healthy volunteers.
目的:测定阿莫西-林克拉维酸钾(14:1)颗粒剂生物等效性。
AIM: To compare efficacy of two designs and three test approaches in individual bioequivalence and estimate sample size.
目的:对两种设计方法、三种检验方法的个体生物等效性的检验效能进行比较,并估计样本含量。
Discuss the question about the samples in individual bioequivalence, give a method how to calculate the number of samples.
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。
CONCLUSION the results of variance analysis and two one-side t test showed that the two formulations were of bioequivalence.
结论方差分析和双向单侧t检验结果表明两种制剂具有生物等效性。
We emphasized in the conclusion that the bioequivalence study for chemical drugs is as important as for biological products.
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。
OBJECTIVE To evaluate the bioequivalence of domestic ramipril capsule and imported ramipril tablet in the healthy volunteers.
目的评价国产雷米普利胶囊与已上市的雷米普利片的人体生物等效性。
Objective to study the bioequivalence of imported and domestic of salmon calcitonin nasal spray in Chinese healthy volunteers.
目的研究国产与进口鲑鱼降钙素喷鼻剂的生物等效性。
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.
目的研究国产和进口硝苯地平控释片的药物动力学和生物等效性。
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