GaBI Journal-Generics and Biosimilars Initiative Journal仿制药与生物类似药倡议期刊
GaBI Journal-Generics and Biosimilars Initiative Journal(英文缩写 GABI J),ISSN 2033-6403,eISSN 2033-6772,中文译名:仿制药与生物类似药倡议期刊 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-10-01 至 2026-09-30，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2023 | 0.300 | Q4 |
| 2024 | 0.200 | Q4 |
| 2025 | 0.300 | Q4 |
GaBI Journal-Generics and Biosimilars Initiative Journal 最新收录文献
-
1. Establishment of reference standards in biosimilar studies.
PMID:日期:2013-07-31When an innovative biological product goes off-patent, biopharmaceutical or biotechnological companies may file an application for regulatory approval of biosimilar products. In practice, however, important information on the innovative (reference) product may not be available for assessment. Thus, it is important to first establish a reference standard while assessing biosimilarity between a biosimilar product and the reference product. In this paper, reference standard is established through the biosimilarity index approach based on a reference-replicated study (or R-R study), in which the reference product is compared with itself under various scenarios. The reference standard can then be used for assessing the degree of similarity between the test and reference drugs in biosimilar studies.
-
2. Pharmacokinetics of Antimicrobials in Obese Children.
PMID:日期:2013Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiologic changes associated with childhood obesity can alter antibiotic pharmacokinetics and optimal body size measures to guide dosing in his population are ill defined. This combination can result in therapeutic failures or drug-related toxicities. This review summarizes pharmacokinetic information for antibiotics in obese children and implications for dosing. We conducted a comprehensive literature search of PubMed, EMBASE, and International Pharmaceutical Abstracts to identify pharmacokinetic studies of antimicrobial agents in obese children. We included the following search terms: and We identified four pharmacokinetic studies of antibiotics in obese children: one for cefazolin and tobramycin, one for gentamicin, and two for vancomycin. Only the cefazolin/tobramycin trial was prospective. The drugs studied differ in their tissue and body water distribution characteristics. Two of the studies (tobramycin and gentamicin) reported pharmacokinetic differences and required dosing modifications in obese children. The lack of pharmacokinetic studies in obese children is pronounced. The scarcity of pharmacokinetic data limits the ability to predict drug disposition using drug physicochemical properties and impedes a rational approach to selection of appropriate body size measures for dosing. Given this knowledge gap, additional trials in obese children are urgently needed and is a public health concern. Pharmacokinetic studies of antimicrobials in obese children are desperately needed to guide dosing and avoid therapeutic failures or unwanted toxicities.