Advances in Pharmacoepidemiology and Drug Safety

Kitasato University, Tokyo, Japan

Biography

Mamoru Narukawa is currently working at the Department of Clinical Medicine, Kitasato University, which is located in Tokyo, Japan and his area of specialization is in Clinical Medicine.

Publications

• 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.. View more»
  

  Abstract PDF