Learning video educational materials
Published by EBStatMax team
Clinical Trial DesignResearch and Drug DevelopmentRegulatory Science
The information proposed in this section provides key elements on the regulation of medicines for Rare Diseases in human and provides support in the:
Health Technology Assessment,
Drug repurposing,
Preclinical suties,
Early access support,
Clinical Development,
Marketing Authorization,
Ethic and legal issues,
Regulatory Agencies.
Learning video Rare Disease Analyser
Published by EBStatMax team
Clinical Trial DesignResearch and Drug Development
A neutral comparison of statistical methods for analyzing longitudinally measured ordinal outcomes in rare diseases
Published by Wiley
Clinical Trial DesignResearch and Drug DevelopmentPeer reviewed journal article on a neutral comparison of statistical methods for longitudinal ordinal outcomes
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How to Analyze Continuous and Discrete Repeated Measures in Small-Sample Cross-Over Trials?
Published by Oxford Academic
Clinical Trial DesignResearch and Drug DevelopmentPeer reviewed journal article on a neutral comparison of statistical methods for longitudinal count data and binary data
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Statistical recommendations for count, binary, and ordinal data in rare disease cross-over trials
Published by Springer
Clinical Trial DesignResearch and Drug DevelopmentPeer reviewed journal article on statistical recommendations for longitudinal cross-over studies in rare disease research
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Learning video project overview
Published by EBStatMax team
Clinical Trial DesignResearch and Drug Development
Learning video statistical recommendations
Published by EBStatMax team
Clinical Trial DesignResearch and Drug DevelopmentLearning Video on the EBStatMax statistical recommendations
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European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). ICH S5 (R3) Guideline on Reproductive Toxicology: Detection of Toxicity to Reproduction for Human Pharmaceuticals. Step 5. 17 February 2020. EMA/CHMP/ICH/544278/1998
Published by European Medicines Agency (EMA)
Animal ModelsClinical TrialsEMAGuidelinePharmaceuticals ToxicityVaccineThis guideline applies to all pharmaceuticals, including biopharmaceuticals, vaccines (and their novel constitutive ingredients) for infectious diseases, and novel excipients that are part of the final pharmaceutical product.
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European Medicines Agency. EMA’S GUIDE ON ADVANCED THERAPY MEDICINAL PRODUCTS. Non-Clinical Development Checklist. Version 1.0 – 29 November 2021
Published by EMA
Gene TherapyMedical ProductsNon-Clinical Development ChecklistEMA’s guide to help developers of gene therapy medicinal products (GTMPs) and cell-based medicinal products (CBMPs) navigate the most important regulatory requirements during the non-clinical development phase
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COMMISSION DIRECTIVE (EU) 2015/565 of 8 April 2015 Amending Directive 2006/86/EC as Regards Certain Technical Requirements for the Coding of Human Tissues and Cells.
Published by European Commission (EC)
Commission DirectiveHuman Tissues and CellsThis Directive amends the Directive 2006/86/EC as regards certain technical requirements for the coding of human tissues and cells
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