Therapeutic equivalence investigations: statistical considerations

✍ Scribed by Joachim Röhmel

• Publisher: John Wiley and Sons
• Year: 1998
• Tongue: English
• Weight: 117 KB
• Volume: 17
• Category: Article
• ISSN: 0277-6715
• DOI: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1703::aid-sim972>3.0.co;2-g

✦ Synopsis

Therapeutic equivalence studies still present problems to regulatory reviewers from many perspectives. This paper is intended to discuss some of these concerns from the statistical viewpoint. There are, however, also some newer approaches which may be particularly useful for the investigation of therapeutic equivalence.