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pro vyhledávání: '"Eunjung Esther Chuh"'
Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies
Autor:
Lewis J. Fermaglich, Johnny Young, Eunjung Esther Chuh, Ru Chen, Julia Lee, Carol Y. Kim, Daiva Shetty, Teena Thomas, Ying Fan
Publikováno v:
Therapeutic innovationregulatory science. 53(1)
The objective of this report is to summarize common deficiencies identified in the filing reviews of abbreviated new drug applications (ANDAs) with clinical endpoint bioequivalence studies and skin irritation, sensitization, and adhesion (I/S/A) stud
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::11678c7bb6742766d421e45f09e91046
https://pubmed.ncbi.nlm.nih.gov/29719976
https://pubmed.ncbi.nlm.nih.gov/29719976
