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Pharmaceutical development of medicines for use in the older population (updated)
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 (updated)
Last updated: 16/10/2020 -
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Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) (updated)
Last updated: 13/10/2020 -
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Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) (updated)
Last updated: 13/10/2020 -
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Data Monitoring Committees issues (updated)
Last updated: 08/10/2020 -
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ICH Q3D Elemental impurities (updated)
Last updated: 01/10/2020 -
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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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Lapatinib product-specific bioequivalence guidance
Last updated: 24/08/2020 -
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Quality of water for pharmaceutical use
Last updated: 20/07/2020 -
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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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Abiraterone product-specific bioequivalence guidance
Last updated: 15/06/2020 -
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Clinical pharmacology and pharmacokinetics: questions and answers
Last updated: 05/06/2020 -
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Dasatinib product-specific bioequivalence guidance
Last updated: 06/05/2020 -
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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 -
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Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence
Last updated: 01/04/2020 -
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Biostatistics
Last updated: 25/03/2020 -
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ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management
Last updated: 04/03/2020 -
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ICH S5 (R3) guideline on reproductive toxicology: Detection of toxicity to reproduction for human pharmaceuticals - step 5
Last updated: 18/02/2020 -
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ICH E9 statistical principles for clinical trials
Last updated: 18/02/2020 -
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Quality of medicines questions and answers: Part 1
Last updated: 05/02/2020 -
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Alectinib product-specific bioequivalence guidance
Last updated: 19/12/2019 -
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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: 22/11/2019 -
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Clinical investigation of medicinal products for the treatment of gout
Last updated: 14/11/2019