Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of atorvastatin in Chinese subjects

2020 ◽  
Vol 58 (02) ◽  
pp. 112-120 ◽  
Author(s):  
Su-Mei Xu ◽  
Juan Yan ◽  
Dai Li ◽  
Dan Li ◽  
Xiao-Min Li ◽  
...  
Keyword(s):  
Generic Drug ◽  
Average Bioequivalence ◽  
Drug Products ◽  
Chinese Subjects

scholarly journals Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products of agomelatine in Chinese subjects

2016 ◽  
Vol 6 (1) ◽  
pp. 71-78 ◽  
Author(s):  
Fang Tang ◽  
Rui Zhou ◽  
Zeneng Cheng ◽  
Guoping Yang ◽  
Aiqiao Chen ◽  
...  
Keyword(s):  
Generic Drug ◽  
Average Bioequivalence ◽  
Drug Products ◽  
Chinese Subjects

scholarly journals Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

2012 ◽  
Vol 14 (4) ◽  
pp. 915-924 ◽  
Author(s):  
Barbara M. Davit ◽  
Mei-Ling Chen ◽  
Dale P. Conner ◽  
Sam H. Haidar ◽  
Stephanie Kim ◽  
...  
Keyword(s):  
Drug Administration ◽  
Generic Drug ◽  
Food And Drug Administration ◽  
Average Bioequivalence ◽  
Drug Products ◽  
The Us

scholarly journals Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study

BMJ ◽  
2018 ◽  
pp. k1180 ◽  
Author(s):  
Rishi J Desai ◽  
Ameet Sarpatwari ◽  
Sara Dejene ◽  
Nazleen F Khan ◽  
Joyce Lii ◽  
...  
Keyword(s):  
Cohort Study ◽  
Generic Drug ◽  
Drug Products

scholarly journals Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

2021 ◽  
Vol 09 (10) ◽  
pp. 23-39
Author(s):  
Md. Imtiaz Hasan ◽  
Shahnaz Akter Shimu ◽  
Akhi Akther ◽  
Ishrat Jahan ◽  
Md. Hamiduzzaman ◽  
...  
Keyword(s):  
Generic Drug ◽  
Drug Products ◽  
Regulatory Aspects ◽  
Pharmaceutical Industries
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