Global Drug Development Based on ICH-E5 Guideline.

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  • ＩＣＨ‐Ｅ５を踏まえた医薬品の国際開発

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Abstract

The ICH-E5 guideline issued in August, 1998 brought great change concept and strategy of drug development not only for Japanese pharmaceutical companies but also US and European companies. As only two years have passed since then, Pfizer's Viagra is so far the only product that obtained NDA approval in Japan with ICH-E5-based development. However many companies are now developing various products based on diverse ICH-E5 strategies and plans, and many successful cases will continuously appear within several years. Incidentally, what is important would be that complete clinical data package consisting of Japanese and foreign clinical data should clearly elucidate clinical efficacy and safety, and provide rationale for dosage and dose regimen. It is reported that number of OPSR consultation with bridging study is increasing year by year. A great level of disclosure of information for OPSR consultation on bridging manners is highly desirable, because many people are strongly concerned with what strategies and plans would be possible. The ICH-E5 guideline highlighted the importance of PK and PD studies in clinical development. They are essentially needed not only for analyzing similarity/difference in PK and PD between Japaneses and Americans/Europeans, but also elucidating correlation of dosage/dose regimen and clinical efficacy/safety. Further great progress of PK and PD studies is highly expected.

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