659 results
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Dasatinib product-specific bioequivalence guidance (updated)
Last updated: 30/04/2021 -
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Sorafenib product-specific bioequivalence guidance
Last updated: 05/02/2021 -
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Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications
Last updated: 02/02/2021 -
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Quality of water for pharmaceutical use
Last updated: 01/02/2021 -
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ICH Q3D Elemental impurities
Last updated: 29/01/2021 -
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Data Monitoring Committees issues
Last updated: 29/01/2021 -
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Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells
Last updated: 17/12/2020 -
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Levothyroxine product-specific bioequivalence guidance
Last updated: 16/12/2020 -
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Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'
Last updated: 11/12/2020 -
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ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs
Last updated: 08/12/2020 -
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Lapatinib product-specific bioequivalence guidance
Last updated: 23/11/2020 -
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Palbociclib product-specific bioequivalence guidance
Last updated: 23/11/2020 -
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Abiraterone acetate product-specific bioequivalence guidance
Last updated: 23/11/2020 -
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Multidisciplinary: vaccines
Last updated: 19/11/2020 -
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Evaluation of anticancer medicinal products in man
Last updated: 16/11/2020 -
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Pharmaceutical development of medicines for use in the older population
Last updated: 22/10/2020 -
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ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
Last updated: 16/10/2020 -
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Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 13/10/2020 -
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Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
Last updated: 13/10/2020 -
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ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - questions and answers
Last updated: 28/08/2020 -
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Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation
Last updated: 01/07/2020 -
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Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials
Last updated: 29/06/2020 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 05/06/2020 -
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ICH Q3C (R6) Residual solvents
Last updated: 04/05/2020 -
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ICH E8 General considerations for clinical studies
Last updated: 07/04/2020