Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

• Główni autorzy: Shunsuke Matsushita (Autor), Keisuke Tachibana (Autor), Tetsuya Kusakabe (Autor), Ryuichi Hirayama (Autor), Yasuo Tsutsumi (Autor), Masuo Kondoh (Autor)
• Format: Książka
• Wydane: Wiley, 2021-05-01T00:00:00Z.
• Hasła przedmiotowe: article
• Dostęp online: Connect to this object online.

For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability. Delayed access to these drugs increases the risk of mortality of patients with...