除本指导原则以外,针对有特殊考虑的药物,FDA会常规发布特殊药物的指导原则BioequivalenceRecommendations for Specific Products,以帮助申办者进行BE试验设计。 一、以药代动力学为终点评价指标的生物等效性研究 1.总体考虑 生物等效性(bioequiv...
[33] FDA. Sponsor Responsibilities-Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Draft Guidance for Industry [EB/OL]. (2006-03-28) [2024-05-20].https:// www.fda.gov/media/150356/download. [34] Janiaud P, Serghiou S, Ioannidis J P ...
生物等效性（bioequivalence，BE）可定义如下：在相似的试验条件下单剂或多剂服用相同摩尔数的治疗组份后...
Statistical Approaches to Establishing Bioequivalence 建立生物等效性的统计方法 Three-Year Exclusivity Determinations for Drug Products 药物产品三年独家经营决定 CATEGORY - Labeling 分类-标签 Dose Banding: Considerations for Labeling 剂量联用:标签的注意事项 Geriatric Information in Human Preion Drug and Biologica...
To address this question, the concepts of population bioequivalence for drug prescribability and individual bioequivalence for drug switchability have been proposed. In this paper, we provide a comprehensive review of the draft FDA guidance on "In Vivo Bioequivalence Studies Based on Population and ...
FDA于2001年颁布《Guidance for Industry StatisticalApproaches to Establishing Bioequivalence》( 生物等效性评价统计方法指导原则) ,介绍了HVD 试验设计和统计方法。 2003 年,《Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations》( 口服药物制剂...
⽣物等效性（bioequivalence，BE）可定义如下：在相似的试验条件下单剂或多剂服⽤相 同摩尔数的治疗组份后，受试制剂的吸收速度和程度与参⽐制剂相⽐没有显著差异。对于⼤多数药物⽽⾔，BE研究着重考察药物⾃制剂释放进⼊机体循环的过程，这种情况 下，通常将受试制剂在机体内的暴露情况与参⽐制剂...
导原则Bioequivalence Recommendatio for Specific Products,以帮助申办者 迚行BE 试验设计。 一、以药代动力学为终点评价指标的生物等效性研究 1.总体考虑 生物等效性(bioequivalence,BE)可定义如下:在相似的试验条件下单剂 或多剂服用相同摩尔数的治疗组份后,受试制剂的吸收速度和程度不参比制剂相比 ...
These documents are the original statistical information taken from the earlier June 1999 draft of this guidance, and also from the added Statistical Information for In Vitro Bioequivalence Data material posted on August 18, 1999. The subsequent implementation will include the estimation of within ...
一、以药代动力学为终点评价指标的生物等效性研究 1.总体考虑 生物等效性(bioequivalence,BE)可定义如下:在相似的试验条件下单剂或多剂服用相同摩尔数的治疗组份后,受试制剂的吸收速度和程度与参比制剂相比没有显著差异。 8、60; 对于大多数药物而言,BE研究着重考察药物自制剂释放进入机体循环的过程,这种情况下,...