ABSTRACT

There are many potential problems and questions that the scientifi c researcher may encounter when attempting to design and carry out a stress-testing study for a pharmaceutical compound. This chapter is intended to address some of the more frequently encountered problems or questions. Since many of the questions are dealt with in more detail in other parts of the book, the reader may be referred to other chapters or publications for further information. We conclude the chapter by summarizing questions that have been received from regulatory agencies in regard to forced stress testing topics.