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. 2007 Dec;48(6):871-7.
doi: 10.3325/cmj.2007.6.871.

Abbreviated clinical study reports with investigational medicinal products for human use: current guidelines and recommendations

Vicente Alfaro  1 , Martín Cullell-Young, Adnan Tanovic
Affiliations
Free PMC article

Abbreviated clinical study reports with investigational medicinal products for human use: current guidelines and recommendations

Vicente Alfaro et al. Croat Med J. 2007 Dec.
Free PMC article
No abstract available

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Figures

Figure 1
Figure 1
Schematic representation of the five modules in the Common Technical Document (CTD). Drawn from International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M4E guideline on CTD (3).
See this image and copyright information in PMC

References

    1. Molzon JA. The International Conference on Harmonization common technical document – global submission format? Food Drug Law J. 2005;60:447–51. - PubMed
    1. Todic M. Dossier for marketing authorization in the European union. Bosn J Basic Med Sci. 2003;3:56–60. - PubMed
    1. CPMP/ICH. 2887/99. ICH M4E. Common technical document for the registration of pharmaceuticals for human use-efficacy. Clinical overview and clinical summary of module 2. Module 5: clinical study reports. London: European Medicines Agency; 2003.
    1. Molzon J. The common technical document: the changing face of the New Drug Application. Nat Rev Drug Discov. 2003;2:71–4. doi: 10.1038/nrd990. - DOI - PubMed
    1. CPMP/ICH. 137/95. ICH topic E3. Structure and Content of Clinical Study Reports. London: European Medicines Agency; 1996.

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