Pharmaceutical Marketing Authorisation Applications (MAAs) and Electronic Support
CANDAs – Computer Assisted Drug Applications History part 1

The development of a medicinal product is a long term project of up to 10 years with an overall success probability of approx. 1:10.000. Final objective of all developmental work is to assess efficacy, safety and quality of the drug substances and the pharmaceutical preparation.
All this knowledge on drug and formulation - established over years - must be compiled in a drug application dossier which will be filed for various authorities around the world to obtain marketing authorisation. To understand the huge amount of data, which is collected during these decade, the drug development process should be understood in general.