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All SubjectsGuideline

Repurposing Medicines Toolkit – Guidance for navigating the process

Published by MRCLife Arc

GuidelineRepurposing

This toolkit aims to provide a guide for researchers, charities and others embarking on repurposing projects. It highlights common activities, issues and considerations at each development stage and signpost to other available resources. The content is mostly styled as questions – what should I be considering at each development stage? It is intended to stimulate thinking and not as a step-by-step guide, which reflects the variable nature of repurposing.

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Biomarker Commercialization Review Tool

Published by Biomarker Commercialization (BIC) consortium

Research and Drug DevelopmentBiomarkerGuidelineBiomarker Commercialisation (BIC) Consortium

The BIC Review Tool is designed to improve communication, it allows an “inventors interview”-type of approach, in addition to being a checklist for Technology Transfer Offices and Researchers. It is designed to improve communication between the stakeholders involved in the commercialization process and to facilitate collaboration. The tool is therefore in a completely different format than the Biomarker Commercialization (BIC) Guide. All introductions and explanations are missing by intention since they can already be found in the BIC Guide, Best & Pitfall Practices handbook or the Regulatory Guide. 

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European Medicines Agency. ICH Topic E15. Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (EMEA/CHMP/ICH/437986/2006). 2007.

Published by European Medicines Agency (EMA)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

EMAGuidelinePharmacogenomicsGenomic DataSample Coding

This guideline contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics and genomic data and sample coding categories. 

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European Medicines Agency. Qualification of Novel Methodologies for Drug Development: Guidance to Applicants (EMA/CHMP/SAWP/72894/2008). 2014.

Published by European Medicines Agency (EMA)

EMAGuidelinePharmaceuticals Drug Development

This guidance is for qualification process addresses innovative drug development methods and tools. It will focus on the use of novel methodologies developed by consortia, networks, public/private partnerships, learned societies and pharmaceutical industry for a specific intended use in pharmaceuticals R&D. 

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EU Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/SWP/465/95).

Published by The European Agency for the Evaluation of Medicinal Products, EMA

EMAGuidelineVaccineToxicityAnimal ModelsPreclinical Testing

This is a note for guidance  on the preclinical evaluation of new vaccine products including combined vaccines, vaccines are those containing antigens not yet described in European Pharmacopoeia monographs or in WHO requirements and vaccines containing live organisms. It indicated the suitable animal models and ethics issues for vaccine preclinical testing. 

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ICH S8 Guideline 2006. Note For Guidance on Immunotoxicity Studies for Human Pharmaceuticals (Chmp/167235/2004).

Published by European Medicines Agency (EMA)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

EMAGuidelineToxicityAnimal ModelsDrug

This guidance is prepared to provide recommendations on nonclinical testing approaches to identify compounds which have the potential to be immunotoxic, and guidance on a weight-of-evidence decision making approach for immunotoxicity testing. 

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