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In Japan in October 2016, the Pharmaceuticals and Medical Devices Agency (PMDA) began to receive electronic data in new drug applications (NDAs). These electronic data are useful to conduct regulatory assessment of sponsors’ submissions and contribute to the PMDA's research. In this article, we summarize the number of submissions of quantitative modeling and simulation (M&S) documents in NDAs in Japan, and we describe our current thinking and activities about quantitative M&S in PMDA.

Tanzawaic acids have been isolated from Penicillium citrinum and their structures were elucidated by spectroscopic analysis. Their relative stereochemistries were also clarified by detailed analyses of 1H–1H coupling constants and NOE data. Tanzawaic acid B (GS-1302-1) significantly inhibits superoxide anion production in human neutrophils.

Tanzawaic Acids A, B, C, and D: Inhibitors of Superoxide Anion Production from Penicillium citrinum -[isolation and structure isolation of the title carboxylic acids (I) and (II)]. -(KURAMOTO, M.; YAMADA, K.; SHIKANO, M.; YAZAWA, K.; ARIMOTO, H.; OKAMURA, T.; UEMURA, D.; Chem. Lett. (1997) 9, 885-886; Dep. Chem., Fac. Sci., Shizuoka Univ., Oya, Shizuoka 422, Japan; EN)