Heberprot Study Documentation
September 08, 2015
News about the inclusion of Heberprot in the Russian List of Essentials Medicines.
| Author: Raquel Maria Garcia Alvarez Version: Final Format: PDF, 3k Previous versions: not available |
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August 31, 2015
Appraisal of non-clinical studies for Nepidermin (Heberprot-P) including data on pharmecokinetics, pharmacodynamics, toxicity as well as safety margin appraisal.
| Author: Alberto Campana Version: Final Format: Available upon request Previous versions: not available |
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July 17, 2015
Organigram containing preliminary study duties for all team members and overview of tasks to be completed.
| Author: Jadranka Rogan Version: 2 Format: PNG image, 51k Previous versions: 1 (not available) |
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July 16, 2015
Current status of the study with goals and timelines. Includes details of pharmacovigilance procedures and published papers.
| Author: Jadranka Rogan Version: 1 Format: Power Point presentation, 915k Previous versions: not available |
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July 15, 2015
Adaptive Licensing Pilot project – Submission Form, a template from the EMA, describing all steps to be taken. Gives brief overview (in 9 major points) of tasks to be acomplished.
| Author: Jadranka Rogan Version: 1 Format: MS Word document, 120k Previous versions: not available |
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