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Pharmaceutical Administration and Regulations in Japan - Nihs

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Fig. 10 Correlation between Development Phases <strong>and</strong> Types of Study<br />

This matrix graph illustrates the relationship between the phases of development <strong>and</strong><br />

types of study by objective that may be conducted dur<strong>in</strong>g each cl<strong>in</strong>ical development of a<br />

new medic<strong>in</strong>al product. The shaded circles show the types of study most usually<br />

conducted <strong>in</strong> a certa<strong>in</strong> phase of development, the open circles show certa<strong>in</strong> types of study<br />

that may be conducted <strong>in</strong> that phase of development but are less usual. Each circle<br />

represents an <strong>in</strong>dividual study. To illustrate the development of a s<strong>in</strong>gle study, one circle<br />

is jo<strong>in</strong>ed by a dotted l<strong>in</strong>e to an <strong>in</strong>set column that depicts the elements <strong>and</strong> sequence of an<br />

<strong>in</strong>dividual study.<br />

2011-3 - 131 -

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