This book is an attempt to summarize information on the fundamentals of
pharmaceutical product development for modern biomedicinal products and to
combine these with specific recommendations for effective planning and management
of applied research and development projects. A reasonable selection of
information was necessary to avoid confusions by too many details. This inevitably
leads to omissions and simplifications, particularly on patent and registration
issues. The reader should bear in mind that these sections are primarily intended to
explain the fundamental rules. For specific advice and interpretation of special
cases the original and official documents should be consulted.
Acknowledgements