REGULATORY STRATEGY OF CLINICAL DEVELOPMENT FOR FIXED COMBINATION MEDICINAL PRODUCTS

Abstract

This article is intended for specialists on drug registration and specialists in clinical trials. There are analyzed the main projects of foreign documents regulating the amount of the registration program and the program of clinical trials required to bring to market the combined drugs. Article clarifies the principal possibility for development of certain combination types and gives comprehensive information about different clinical development strategy types of fixed combination medicinal products supported with evaluation of their applicability according to intended claim of the combination. Some practical recommendations for study design selection are also given.

Keywords

• clinical trials
• clinical development program
• fixed combination medicinal products