Ing. Helmut Schütz

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Revision of Guidelines

Japan – NIHS

On 24 November 2006 Japan’s NIHS published revisions to four BE Guidelines and corresponding Questions & Answers Documents.

Revised Guidelines and corresponding Q&A Documents are:

1. Guideline for BE Studies for Generic Products (updates Dec 1997 version)
2. Guideline for BE Test on Oral Solid Preparation with Different Drug Contents (updates Feb 2000 version)
3. Guideline for BE Test on Oral Solid Preparation for which the Formulation has been changed (updates Feb 2000 version)
4. Guideline for BE Studies of Generic Products for Topical Use (updates Jul 2003 version)

A new ‘Guideline for BE Studies of Adding Dosage Form for Topical Use’ was also published.

The ‘Guideline on Oral Prolonged Release Dosage Forms’ (Mar 1988) was not revised.

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Update

On 29 February 2012 guidelines and Q&As were revised; for details see here.