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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
Autor:
Johnny Young
Publikováno v:
Psychoanalytic review. 94(6)
The director David Lynch simultaneously stimulates and challenges viewers to look beyond the screen image. His films are an amalgam of introspection, metaphor, and uncertainty, blurring the line between fiction and reality. Lynch’s unbridled, somew