scholarly journals An Overview on Bioequivalence: Regulatory Consideration for Generic Drug Products

2010 ◽  
Vol 02 (04) ◽  
Author(s):  
Asif M. Tamboli Pavan Todkar ◽  
Priti Zope F.J. Sayyad
Keyword(s):  
Generic Drug ◽  
Drug Products

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

Reasons for patients’ generic drug switching at the pharmacy counter: a pilot study

2021 ◽  
Vol 10 (3) ◽  
pp. 119-122
Author(s):  
Pieter J Glerum ◽  
Mert Hayta ◽  
David M Burger ◽  
Cees Neef ◽  
Marcel L Bouvy ◽  
...  
Keyword(s):  
Pilot Study ◽  
The Netherlands ◽  
Generic Drug ◽  
Active Substance ◽  
Drug Product ◽  
Product Distribution ◽  
Economic Incentives ◽  
Drug Shortages ◽  
Drug Products ◽  
Drug Switching

Background: Drug switching describes switching between drug products with the same active substance. Drug switching occurs commonly in the Netherlands and mostly between generic drug products, however, the specific reasons for switching are incompletely understood. Methods: To document reasons for drug switches between products with the same active substance in the Netherlands. Results: In total, 207 drug switches were recorded. Most drug switches were caused by nationwide drug shortages (32%, n = 66) and the Dutch price-based tender system (23%, n = 47). Other reasons for switching included deals between pharmacists and wholesalers (12%, n = 25), distribution issues at wholesalers (11%, n = 22), and a financially favourable margin for pharmacists (11%, n = 21). Conclusion: This study indicates that drug shortages and the Dutch price-based tender system are likely to be major causes of drug switches in the Netherlands. However, other reasons, such as drug product distribution issues and local economic incentives, were also identified.

scholarly journals Comparative Risk Assessment of Formulation Changes in Generic Drug Products: A Pharmacology/Toxicology Perspective

2015 ◽  
Vol 146 (1) ◽  
pp. 2-10 ◽  
Author(s):  
Sree Rayavarapu ◽  
Elena Braithwaite ◽  
Robert Dorsam ◽  
James Osterhout ◽  
Lesley-Anne Furlong ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Generic Drug ◽  
Comparative Risk Assessment ◽  
Drug Products ◽  
Comparative Risk

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 ◽  
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