Učitavanje...

Data exclusivity through New Drug Reexamination in Korea: sibutramine hydrochloride (Reductil®) vs. sibutramine mesylate (Slimmer®) as an example

The ‘equivalent-or-more-but-not-the-same-data’ provision in the Regulation on the Safety and Efficacy Evaluation of New Drug in Korea has served as the de facto data exclusivity term for any drug identical to a product subject to new drug reexamination. The legal debate that occurred between Abbott...

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Bibliografski detalji
Izdano u:Transl Clin Pharmacol
Glavni autor: Lee, Howard
Format: Artigo
Jezik:Inglês
Izdano: Korean Society for Clinical Pharmacology and Therapeutics 2018
Teme:
Online pristup:https://ncbi.nlm.nih.gov/pmc/articles/PMC6989260/
https://ncbi.nlm.nih.gov/pubmed/32055548
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.12793/tcp.2018.26.2.49
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