Mamoru Narukawa

Kitasato University, Tokyo, Japan

  • Research Article   
    Post-Marketing Change in Dosage and Administrations of FDA-Approved Drugs Between 2000 and 2017
    Author(s): Masako Ashida* and Mamoru Narukawa

    Purpose: Relevant information on the change in dosage in the post-marketing stage would be useful in considering future clinical development strategies. Therefore, we investigated the content and timing of post-marketing dosage changes using labeling information for New Molecular Entities (NMEs) approved by the FDA. Methods: We compiled a list of NMEs approved by the FDA between January 1, 2000, and December 31, 2017, using the FDA’s website, and the descriptions of the section “dosage and administration” in the latest labeling as of December 31, 2018, were compared with that for the initial approval for each drug. The time required for the change in dosage for the main patient population was estimated using survival analysis. Results: Of the 432 NMEs, 425 (98%) were evaluable. Dosage chang.. Read More»

    Abstract PDF