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  • Rising COVID-19 cases impede progress of bioequivalence test
  • by Chon, Seung-Hyun | translator Alice Kang | Apr 8, 2022 06:08am
ahead drug pricing reevaluations
Difficult recruiting subjects, dropouts due to confirmed COVID-19 cases lead to additional recruitment, disrupting the test schedule
Unclear whether companies will be able to meet the drug re-evaluation deadline next February¡¦companies request ¡°deadline extensions.¡±

Pharmaceutical companies are having trouble conducting bioequivalence tests for the development of generics due to COVID-19. The spread of COVID-19 has made it difficult for companies to recruit subjects, and even those recruited are dropping out after being confirmed with COVID-19, causing disruptions in the companies¡¯ schedules. With delays inevitable due to the unexpected pandemic, pharmaceutical companies have been asking authorities to extend the drug pricing reevaluation deadlines that were set for February next year.

According to industry sources on the 8th, several pharmaceutical companies have expressed their difficulties in progressing their ongoing bioequivalence tests due to the surge of COVID-19 cas
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