Drug discovery in renal disease - Towards a more efficient framework

Toshio Miyata, Tsuyoshi Ando, Hisami Hiragi, Kanako Watanabe, Fumi Yamamoto, Douglas E. Vaughan, Tatsuo Kurokawa, Yoshiteru Oshima, Charles Van Ypersele De Strihou, Masahiro Takeuchi

研究成果: Article査読

抄録

The time and cost involved in bringing new drugs to the market hamper their approval. This problem is especially apparent in the case of renal diseases. Efficient drug research requires an a priori understanding of disease pathophysiology, target validation, rational and efficient drug discovery strategies and early testing of the physiological and pharmacological effects of the new agent in humans. Drug development initiated by academia benefits from international research networks and relies on internationally acceptable high-quality nonclinical data packages and bulk investigational drugs. Academics should, therefore, better understand pharmaceutical practice regulations and novel, efficient drug-development strategies. Many researchers remain unfamiliar with these areas and should collaborate with regulatory authorities to discover and validate surrogate markers for use in drug development, and to efficiently and effectively maximize the benefits and minimize the adverse effects of new drugs. The Japanese government and regulatory authorities have implemented a framework to encourage such collaborations; extension of this framework beyond its current reach is envisaged.

本文言語English
ページ(範囲)290-296
ページ数7
ジャーナルNature Reviews Nephrology
10
5
DOI
出版ステータスPublished - 2014

ASJC Scopus subject areas

  • 腎臓病学

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