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The format and structure of ICH M7 [1] is understandably very similar to that of the preceding regional guidelines, with specific sections focused on quality and safety aspects, although terminology does differ. Crucially, the fundamental concept upon which the guideline is predicated has not changed; the principle of a TTC, i.e. a virtually safe dose (VSD), remains the underpinning principle upon which the guideline is based. In addition to the overall framework, there are additional sections intended to provide definitive guidance in specific areas, these include:

1 Established Products

2 Documentation

3 Case Studies

These and other sections are now described in detail below.