A system of modules is described for the preparation of core dossiers (manufacturing and controls section). It consists of individual monographs of the narrowest subject scope, such that the information required for any local drug registration dossier may be selected from the whole.
GurienHKleeGM. Core requirements for international registration of drugs. Drug Inf J.1989;23: 545–559.
2.
DinnerAFoseJ.Effectively dealing with the special chemical and pharmaceutical considerations in the US and EEC for biotechnology products — Part 2. Drug Inf J.1989;23: 501–509.
3.
RosierJDemoenP.Requirements for chemical and pharmaceutical data in support of clinical trial applications in the United Kingdom, Canada, the USA, the Nordic Countries, and Australia. Drug Inf J.1990;24: 427–447.
